Scientific Documentation

HY110, Hydrogen Peroxide Topical Solution, USP

Not appropriate for regulatory submission. Please visit www.spectrumchemical.com or contact Tech Services for the most up‐to‐date information contained in this information package.

Spectrum Chemical Mfg Corp 769 Jersey Avenue New Brunswick, NJ 08901 Phone 732.214.1300

Ver4.04 29.July.2019 Dear Customer,

Thank you for your interest in Spectrum’s quality products and services.

Spectrum has been proudly serving the scientific community for over 45 years. It is our mission to manufacture and distribute fine chemicals and laboratory products with Quality and delivery you can count on every time.

To accomplish our mission, Spectrum utilizes our sourcing leverage and supplier qualification expertise in offering one of the industry’s most comprehensive line of fine chemical products under one brand, in packaging configurations designed to meet your research and production requirements. Our product grades include: USP, NF, BP, EP, JP, FCC, ACS, KSA, Reagent grade, as well as DEA controlled substances. We operate facilities in the United States on the East Coast, West Coast, as well as in Shanghai, China in order to provide the best logistical support for our customers.

At Spectrum, Quality is priority number one. Suppliers with the best qualifications are preferred and we employ full-functioning in-house analytical laboratories at each of our facilities. Our facilities and systems are USFDA registered and ISO certified. We frequently host customer audits and cherish opportunities for improvements. Quality is engrained into our culture. Quality is priority number one.

In the following pages, we have designed and prepared documented scientific information to aid you in your initial qualification or your continual use of our products. Please do not hesitate to contact us if further information or the most up-to-date documentation is desired from any of the covered areas.

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29.July.2019

HY110, Hydrogen Peroxide Topical Solution, USP

Table of Contents

 Product Specification

 Safety Data Sheet (SDS)

 Certification of Quality Management System (QMS)

 Certification of current Good Manufacturing Practices (cGMP)

 Product Allergen Statement

 Product Certificate of Analysis Sample(s)

 General Label Information – Sample Label

 General Lot Numbering System Guidance

 Stability – Shelf Life Guidance

 Halal Certificate

Specification for Hydrogen Peroxide Topical Solution, USP (HY110)

Item Number HY110

Item Hydrogen Peroxide Topical Solution, USP

CAS Number 7722-84-1

Molecular Formula H2O2 Molecular Weight 34.01 MDL Number Synonyms Hydrogen Peroxide, 3 Percent Solution

Test Specification Min Max

ASSAY (H2O2) 2.5 3.5 % ACIDITY 2.5 ml NONVOLATILE RESIDUE (w/v) 0.15 % NO TURBIDITY OR BARIUM PRECIPITATE ELEMENTAL IMPURITIES: TIN (Sn) AS REPORTED LIMIT OF PRESERVATIVES 0.05 % BLUE COLOR PASSES IDENTIFICATION INTO ETHER LAYER EXPIRATION DATE DATE OF MANUFACTURE APPEARANCE RESIDUAL SOLVENTS AS REPORTED SAFETY DATA SHEET

Preparation Date: 7/28/2015 Revision date 8/1/2019 Revision Number: G2

1. IDENTIFICATION Product identifier

Product code: HY110 Product Name: HYDROGEN PEROXIDE TOPICAL SOLUTION, USP

Other means of identification Synonyms: Hydrogen Peroxide Topical Solution Hydrogen Peroxide 3% CAS #: Mixture RTECS # Not available CI#: Not available

Recommended use of the chemical and restrictions on use Recommended use: No information available. Uses advised against No information available

Supplier: Spectrum Chemical Mfg. Corp 14422 South San Pedro St. Gardena, CA 90248 (310) 516-8000

Order Online At: https://www.spectrumchemical.com Emergency telephone number Chemtrec 1-800-424-9300 Contact Person: Tom Tyner (USA - West Coast) Contact Person: Ibad Tirmiz (USA - East Coast)

2. HAZARDS IDENTIFICATION

Classification

This chemical is considered hazardous by the 2012 OSHA Hazard Communication Standard (29 CFR 1910.1200)

Considered a dangerous substance or mixture according to the Globally Harmonized System (GHS)

Skin corrosion/irritation Category 2 Serious eye damage/eye irritation Category 2A

Label elements

Warning

Hazard statements Causes skin irritation Causes serious eye irritation

Product code: HY110 Product name: HYDROGEN Page 1 / 14 PEROXIDE TOPICAL SOLUTION, USP Hazards not otherwise classified (HNOC) Not Applicable

Other hazards Harmful to aquatic life with long lasting effects Harmful to aquatic life

Precautionary Statements - Prevention Wash face, hands and any exposed skin thoroughly after handling Wear protective gloves Wear eye/face protection

Precautionary Statements - Response

IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical attention. IF ON SKIN: Wash with plenty of water If skin irritation occurs: Get medical attention Take off contaminated clothing and wash it before reuse

3. COMPOSITION/INFORMATION ON INGREDIENTS

Component CAS No Weight-% Hydrogen peroxide 7722-84-1 2.5-3.5

4. FIRST AID MEASURES

First aid measures

General Advice: National Capital Poison Center in the United States can provide assistance if you have a poison emergency and need to talk to a poison specialist. Call 1-800-222-1222.

Skin Contact: Wash off immediately with soap and plenty of water removing all contaminated clothing and shoes. Get medical attention. If skin irritation persists, call a physician.

Eye Contact: Flush eyes with water for 15 minutes. Get medical attention. If symptoms persist, call a physician.

Inhalation: Move to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Get medical attention.

Ingestion: Do not induce vomiting without medical advice. Never give anything by mouth to an unconscious person. Consult a physician if necessary.

Most important symptoms and effects, both acute and delayed

Symptoms Irritating to eyes and skin Eye contact may result in redness or pain May cause burning or stinging sensation, redness of the skin, inflammation of the skin.

Product code: HY110 Product name: HYDROGEN Page 2 / 14 PEROXIDE TOPICAL SOLUTION, USP May cause irritation of respiratory tract May cause irritiation to mucous membranes May cause mild throat irritation Coughing Ingestion may cause gastrointestinal irritation, nausea, vomiting, and diarrhea

Indication of any immediate medical attention and special treatment needed

Notes to Physician: Treat symptomatically.

Protection of first-aiders First-Aid Providers: Avoid exposure to blood or body fluids. Wear gloves and other necessary protective clothing. Dispose of contaminated clothing and equipment as bio-hazardous waste.

5. FIRE-FIGHTING MEASURES

Extinguishing Media Suitable Extinguishing Media: The product is not flammable. If it is involved in a fire, extinguish the fire using an agent suitable for the type of surrounding fire.

Unsuitable Extinguishing Media: No information available.

Specific hazards arising from the chemical

Hazardous combustion products No information available.

Specific hazards No information available.

Special Protective Actions for Firefighters

Specific Methods: No information available

Special Protective Equipment for Firefighters: As in any fire, wear self-contained breathing apparatus pressure-demand, MSHA/NIOSH (approved or equivalent) and full protective gear

6. ACCIDENTAL RELEASE MEASURES

Personal precautions, protective equipment and emergency procedures

Personal Precautions: Ensure adequate ventilation. Do not touch damaged containers or spilled material unless wearing appropriate protective clothing. Wear personal protective equipment. Avoid contact with skin, eyes and clothing.

Environmental precautions Prevent further leakage or spillage if safe to do so. Prevent entry into waterways, sewers, basements or confined areas. Prevent product from entering drains. Do not let this chemical enter the environment.

Methods and material for containment and cleaning up

Methods for containment Stop leak if you can do it without risk. In case of large spill, dike if needed. Dike far ahead of liquid spill for later disposal.

Methods for cleaning up Absorb spill with inert material (e.g. vermiculite, dry sand or earth), then place in a suitable chemical waste container. Clean contaminated surface thoroughly.

7. HANDLING AND STORAGE

Product code: HY110 Product name: HYDROGEN Page 3 / 14 PEROXIDE TOPICAL SOLUTION, USP Precautions for safe handling

Technical Measures/Precautions: Provide sufficient air exchange and/or exhaust in work rooms. Keep away from incompatible materials.

Safe Handling Advice: Wear personal protective equipment. Avoid contact with skin, eyes and clothing. Do not ingest. Do not breathe vapors or spray mist. Do not smoke. Use only in well-ventilated areas. Handle in accordance with good industrial hygiene and safety practice.

Conditions for safe storage, including any incompatibilities

Technical Measures/Storage Conditions: Sensitive to light. Store in light-resistant containers. Keep container tightly closed in a dry and well-ventilated place. Store at room temperature in the original container. Store away from incompatible materials.

Incompatible Materials: Strong reducing agents Strong bases Metals Combustible materials Organic materials Alcohols Acids Acetic anhydride Acetone Incompatible with reducing materials, alkalies, ethers (dioxane, furfuran, tetrahydrofuran), Metals (eg. potassium, sodium lithium, iron, copper, brass, bronze, chromium, zinc, lead, silver, nickel, manganese, platinum, cobalt, iridium, gold, tungsten, osmium, palladium), metal oxides (eg. cobalt oxide, iron oxide, lead oxide, lead hydroxide, manganese oxide), metal salts (eg. calcium permanganate, salts of iron), asbestos, vanadium, molybdeum, triethylamine, palladium, sodium pyrophosphate, carboxylic acids, cyclopentadiene, formic acid, chlorosulfonic acid, carboxylic acids, acetic acid, nitric acid, rust, ketones, sodium carbonate, sodium borate, aniline, mercurous chloride, sodium pyrophosphate, hexavalent chromium compounds, tetrahydrofuran, sodium fluoride, potassium permanganate, urea, manganese dioxide, hydrogen selenide, charcoal, coal, sodium borate, cyclopentadiene, glycerine, cyanides (potassium, cyanide, sodium cyanide), nitrogen compounds

8. EXPOSURE CONTROLS/PERSONAL PROTECTION Control parameters

National occupational exposure limits

United States

Component CAS No OSHA NIOSH ACGIH AIHA WEEL Hydrogen peroxide 7722-84-1 1 ppm TWA 1 ppm TWA 1 ppm TWA None 1.4 mg/m3 TWA 1.4 mg/m3 TWA

Canada

Component CAS No Canada - Alberta Canada - British Canada - Ontario Canada - Quebec Columbia Hydrogen peroxide 7722-84-1 1 ppm TWA 1 ppm TWA 1 ppm TWA 1 ppm TWAEV 1.4 mg/m3 TWA 1.4 mg/m3 TWAEV

Australia and Mexico

Component CAS No Australia Mexico Hydrogen peroxide 7722-84-1 1 ppm TWA 1 ppm TWA

Product code: HY110 Product name: HYDROGEN Page 4 / 14 PEROXIDE TOPICAL SOLUTION, USP 1.4 mg/m3 TWA 1.5 mg/m3 TWA 2 ppm STEL 3 mg/m3 STEL

Appropriate engineering controls

Engineering measures to reduce exposure: Ensure adequate ventilation. Provide exhaust ventilation or other engineering controls to keep the airborne concentrations of vapors and mist below their respective threshold limit value.

Individual protection measures, such as personal protective equipment

Personal Protective Equipment

Eye protection: Goggles

Skin and body protection: Chemical resistant apron Long sleeved clothing Gloves

Respiratory protection: Respiratory protection is not necessary for normal handling. Good room ventilation or use of local exhaust (fume hood) is sufficient. Use a vapor respirator under conditions where exposure to the substance is apparent (e.g. generation of high concentrations of mist or vapor, inadequate ventilation, development of respiratory tract irritation), and engineering controls are not feasible. Be sure to use an approved/certified respirator or equivalent.

Hygiene measures: Wear suitable gloves and eye/face protection Avoid contact with skin, eyes and clothing. When using, do not eat, drink or smoke. Wash hands and face before breaks and immediately after handling the product

9. PHYSICAL AND CHEMICAL PROPERTIES

Physical state: Appearance: Color: Liquid No information available. Clear.

Odor: Taste Formula Slight. Bitter. Sharp. No information available

Molecular/Formula weight (g/mole): Flammability (solid, gas) Flashpoint (°C/°F): No information available no data available No information available

Flash Point Tested according to: Autoignition Temperature (°C/°F): Lower Explosion Limit (%): Not available No information available No information available

Upper Explosion Limit (%): Melting point/range(°C/°F): Decomposition temperature(°C/°F): No information available -0.43°C/31.2°F No information available

Boiling point/range(°C/°F): Bulk density: Density (g/cm3): 101.56°C/214.8°F No information available 1.01

Specific gravity: pH Vapor pressure @ 20°C (kPa): No information available 7 2.24

Evaporation rate: Vapor density: VOC content (g/L): No information available 0.64 No information available

Product code: HY110 Product name: HYDROGEN Page 5 / 14 PEROXIDE TOPICAL SOLUTION, USP Odor threshold (ppm): Partition coefficient Viscosity: No information available (n-octanol/water): No information available No information available

Miscibility: Solubility: No information available Soluble in Water Soluble in diethyl ether

10. STABILITY AND REACTIVITY Reactivity No information available

Chemical stability

Stability: Stable under recommended storage conditions.

Possibility of Hazardous Reactions: Hazardous polymerization does not occur

Conditions to avoid: Heat. Exposure to light.

Hazardous decomposition No information available. products:

Other Information Corrosivity: No information available

Special Remarks on Corrosivity: No information available

11. TOXICOLOGICAL INFORMATION

Information on likely routes of exposure

Product code: HY110 Product name: HYDROGEN Page 6 / 14 PEROXIDE TOPICAL SOLUTION, USP Principal Routes of Exposure: Ingestion. Inhalation. Eyes. Skin.

Acute Toxicity

Component Information

Hydrogen peroxide CAS No 7722-84-1 LD50/oral/rat = 1518 mg/kg Oral LD50 Rat LD50/oral/mouse = No information available LD50/dermal/rabbit = 2000 mg/kg Dermal LD50 Rabbit; = 9200 mg/kg Dermal LD50 Rabbit LD50/dermal/rat = 4060 mg/kg LC50/inhalation/rat = 2 g/m3 Inhalation LC50 Rat 4 h LC50/inhalation/mouse = No information available Other LD50 or LC50information = No information available

Product Information

LD50/oral/rat = Value - Acute Toxicity = No information available

LD50/oral/mouse = Value - Acute Tox = No information available

LD50/dermal/rabbit Value - Acute Toxicity = No information available

LD50/dermal/rat VALUE - Acute Tox = No information available

LC50/inhalation/rat VALUE-Vapor = No information available VALUE-Gas = No information available VALUE-Dust/Mist = No information available

LC50/Inhalation/mouse VALUE-Vapor = No information available VALUE - Gas = No information available VALUE - Dust/Mist = No information available

Symptoms

Skin Contact: Causes skin irritation. May cause reddening of the skin and temporary discoloration/whitening of the skin. It may be absorbed through the skin. If absorbed through the skin in very large amounts, it may affect behavior/central nervous system (convulsions), and lungs (pulmonary emboli).

Eye Contact: Causes serious eye irritation. Symptoms may include burning sensation, redness, inflammation, pain, and possible corneal edema, and corneal cloudiness.

Inhalation Health injuries are not known or expected under normal use. If mist is generated and inhaled in large quantities, it may cause respiratory tract irritation, coughing, laryngitis, bronchitis, dyspnea, headache, nausea, vomiting, and possibly pulmonary edema.

Product code: HY110 Product name: HYDROGEN Page 7 / 14 PEROXIDE TOPICAL SOLUTION, USP Ingestion Ingestion of large doses may cause digestive tract/gastrointestinal tract irritation (irritation or possible blistering of the tongue, buccal muosa/mouth, throat, and stomach) with nausea, vomiting, hypermotility, and diarrhea. May cause difficulty in swallowing, stomach distension. May affect blood (change in leukocyte count, pigmented or nucleated red blood cells). May affect behavior/central nervous system. May affect cardiovascular system and cause vascular collapse and damage.

Aspiration hazard No information available.

Delayed and immediate effects as well as chronic effects from short and long-term exposure

Chronic Toxicity Prolonged or repeated skin contact may cause dermatitis. Continued use of dilute hydrogen peroxide (3%) solution as a mouth wash, even at half-strength, may cause hypertrophied filiform papillae of the tongue ("hairy tongue") , which disappears after it is discontinued. Prolonged or repeated inhalation may affect the blood (changes in serum composition).

Sensitization: No information available.

Mutagenic Effects: For Hydrogen Peroxide 3% solution: Mutations in microorganisms Experiments with bacteria and/or yeast have shown mutagenic effects

Carcinogenic effects: For Hydrogen Peroxide:. Not classifiable as to its carcinogenicity to humans. Showed carcinogenic effects in animal experiments. The evidence of carcinogenicity in humans is limited , but experimentally proven in animals.

Component CAS No IARC ACGIH - NTP OSHA HCS - Australia - Australia - Carcinogens Carcinogens Notifiable Prohibited Carcinogenic Carcinogenic Substances Substances Hydrogen peroxide 7722-84-1 Group 3 A3 Confirmed Not listed Not listed Not listed Not listed -Monograph 71 Animal [1999] Carcinogen Supplement 7 with Unknown [1987] Relevance to Monograph 36 Humans [1985] ACGIH (American Conference of Governmental Industrial Hygienists)

IARC (International Agency for Research on Cancer)

NTP (National Toxicology Program)

OSHA (Occupational Safety and Health Administration of the US Department of Labor)

Reproductive toxicity No data is available

Reproductive Effects: No information available Developmental Effects: No information available Teratogenic Effects: No information available

Specific Target Organ Toxicity

STOT - single exposure No information available. STOT - repeated exposure No information available. Target Organs: No information available.

Product code: HY110 Product name: HYDROGEN Page 8 / 14 PEROXIDE TOPICAL SOLUTION, USP 12. ECOLOGICAL INFORMATION

Ecotoxicity

Ecotoxicity effects: Aquatic environment.

Hydrogen peroxide - 7722-84-1 Algae/aquatic plants 2.5 mg/L EC50 Chlorella vulgaris 72 h Fish 16.4 mg/L LC50 Pimephales promelas 96 h 1 18 - 56 mg/L LC50 Lepomis macrochirus 96 h static 1 10.0 - 32.0 mg/L LC50 Oncorhynchus mykiss 96 h static 1 Crustacea 18 - 32 mg/L EC50 Daphnia magna 48 h 7.7 mg/L EC50 Daphnia magna 24 h

Persistence and degradability: No information available

Bioaccumulative potential: No information available.

Mobility in soil No information available Other adverse effects No information available.

13. DISPOSAL CONSIDERATIONS

Disposal Methods

Waste from residues / unused products: Waste must be disposed of in accordance with Federal, State and Local regulation.

Contaminated packaging: Empty containers should be taken for local recycling, recovery or waste disposal. Do not re-use empty containers Dispose of as unused product.

Component CAS No RCRA - F Series RCRA - K Series RCRA - P Series RCRA - U Series Wastes Wastes Wastes Wastes Hydrogen peroxide 7722-84-1 None None None None

14. TRANSPORT INFORMATION

DOT UN-No: Not Regulated Proper Shipping Name: No information available Hazard Class No information available Subsidiary Class No information available Packing group: No information available Emergency Response Guide No information available Number Marine Pollutant No data available DOT RQ (lbs): No information available Special Provisions No Information available Symbol(s): No information available Description: No information available

TDG (Canada) UN-No: Not Regulated Proper Shipping Name: No information available Hazard Class No information available

Product code: HY110 Product name: HYDROGEN Page 9 / 14 PEROXIDE TOPICAL SOLUTION, USP Subsidiary Risk: No information available Packing Group: No information available Marine Pollutant No Information available Description: No information available

ADR UN Number Not regulated Proper Shipping Name: No information available Transport hazard class(es) No information available Packing group No information available Subsidiary Risk: No information available

IMDG UN-No: Not Regulated Proper Shipping Name: No information available Hazard Class: No information available Subsidiary Risk: No information available Packing Group: No information available Marine Pollutant No information available

RID UN Number Not Regulated Proper Shipping Name: No information available Transport hazard class(es) No information available Subsidiary Risk: No information available Packing group No information available

ICAO (air) UN-No: Not Regulated Proper Shipping Name: No information available Hazard Class No information available Subsidiary Risk: No information available Packing Group: No information available

IATA UN Number Not Regulated Proper Shipping Name: No information available Transport hazard class(es) No information available Subsidiary Risk: No information available Packing group No information available Precautionary Statements - No information available Response Special Provisions No information available

15. REGULATORY INFORMATION

International Inventories

Component CAS No U.S. TSCA KOREA KECL Philippines Japan ENCS China IECSC Australia EINECS-No. (PICCS) (AICS) Hydrogen peroxide 7722-84-1 PresentACTIV Present Present Present Present Present Present E KE-20204 (1)-419 231-765-0

U.S. Regulations

Hydrogen peroxide Massachusetts RTK: Present

Product code: HY110 Product name: HYDROGEN Page 10 / 14 PEROXIDE TOPICAL SOLUTION, USP Massachusetts EHS: extraordinarily hazardous New Jersey RTK Hazardous Substance List: 1015 New Jersey (EHS) List: 1015 500 lb TPQ New Jersey - Discharge Prevention - List of Hazardous Substances: Present Pennsylvania RTK: Environmental hazard Present Pennsylvania RTK - Environmental Hazard List Present Michigan PSM HHC: = 7500 lb TQ 52% by weight or greater Minnesota - Hazardous Substance List: Present New York Release Reporting - List of Hazardous Substances: 1 lb RQ California Directors List of Hazardous Substances: Present FDA - Food Additives Generally Recognized as Safe (GRAS): 21 CFR 184.1366 FDA - Direct Food Additives 21 CFR 173.315, 21 CFR 173.356 FDA - 21 CFR - Total Food Additives 133.113, 133.118, 133.136, 133.144, 133.195, 160.105, 160.145, 160.185, 172.167, - List Sourced from EAFUS 172.723, 172.814, 172.892, 173.315, 173.356, 173.370, 175.105, 178.1005, 178.1010, 184.1366

California Prop. 65: Safe Drinking Water and Toxic Enforcement Act of 1986.

Chemicals Known to the State of California to Cause Cancer: This product does not contain a chemical requiring a warning under California Prop. 65. (See table below)

Chemicals Known to the State of California to Cause Reproductive Toxicity: This product does not contain a chemical requiring a warning under California Prop. 65. (See table below)

Component CAS No Carcinogen Developmental Toxicity Male Female Reproductive Reproductive Toxicity Toxicity: Hydrogen peroxide 7722-84-1 Not Listed Not Listed Not Listed Not Listed

CERCLA/SARA

Component CAS No CERCLA - Section 302 Section 302 Section 313 - Section 313 - Hazardous Extremely Extremely Chemical Category Reporting Substances and Hazardous Hazardous de minimis their Reportable Substances Substances and Quantities and TPQs RQs Hydrogen peroxide 7722-84-1 None 1000 lb TPQ None None None 1000 lb EPCRA RQ

U.S. TSCA

Component CAS No TSCA Section 5(a)2 - Chemicals TSCA 8(d) -Health and Safety With Significant New Use Rules Reporting (SNURS) Hydrogen peroxide 7722-84-1 Not Applicable Not Applicable

Canada

WHIMIS 2015 - GHS Classifications

WHMIS 2015 Hazard Classification Not a dangerous product according to HPR classification criteria. Information:

Component WHMIS 2015 Hazard Classification Hydrogen peroxide Oxidizing liquids - Category 1: H271 May cause fire or explosion, 7722-84-1 ( 2.5-3.5 ) strong oxidizer.; Oxidizing liquids - Category 3: H272 May intensify fire, oxidizer. (9% aqueous solution); Oxidizing liquids - Undefined: (20% aqueous solution; hazard class was established from consulted scientific literature but did not allow to specify hazard category); Acute toxicity - Oral - Category 4: H302 Harmful if swallowed.; Acute toxicity - Dermal - Category 4: H312 Harmful in contact with skin. (70%); Health Hazard Not Otherwise

Product code: HY110 Product name: HYDROGEN Page 11 / 14 PEROXIDE TOPICAL SOLUTION, USP Classified - Category 1: Causes severe damage to the respiratory tract; Skin corrosion/irritation - Category 1: H314 Causes severe skin burns and eye damage.; Serious Eye Damage/Eye Irritation - Category 1: H318 Causes serious eye damage.; Specific target organ toxicity - Single exposure - Category 3: H335 May cause respiratory irritation. (9% aqueous solution)

Canada Hazardous Products Regulation This product has been classified according to the hazard criteria of the HPR (Hazardous Products Regulation) and the SDS contains all of the information required by the HPR

DSL/NDSL

Component CAS No Canada (DSL) Canada (NDSL) Hydrogen peroxide 7722-84-1 Present Not Listed

Component CAS No CEPA Schedule I - Toxic Substances Hydrogen peroxide 7722-84-1 Not listed Component CAS No CEPA - 2010 Greenhouse Gases Subject to Mandatory Reporting Hydrogen peroxide 7722-84-1 Not listed

EU Classification

EU GHS - SV - CLP 1272/2008

Component CAS No EU GHS - SV - CLP (1272/2008) Hydrogen peroxide 7722-84-1 Oxidizing liquids - Ox. Liq. 1: H271 May cause fire or explosion, strong oxidizer. (C >= 70 %; Correct classification for physical hazards could not be established); Acute toxicity - Oral - Acute Tox. 4: H302 Harmful if swallowed. (Minimum classification); Acute toxicity - Inhalation - Acute Tox. 4: H332 Harmful if inhaled. (Minimum classification); Skin corrosion/irritation - Skin Corr. 1A: H314 Causes severe skin burns and eye damage. (C >= 70 %; Concentration limits for acute toxicity cannot be translated into GHS from the DSD especially when minimum classifications are given)008-003-00-9 Oxidizing liquids - Ox. Liq. 1: H271 May cause fire or explosion, strong oxidizer. (C >= 70 %; Correct classification for physical hazards could not be established); Oxidizing liquids - Ox. Liq. 2: H272 May intensify fire, oxidizer. (50 % <= C <70 %; Correct classification for physical hazards could not be established); Skin corrosion/irritation - Skin Corr. 1A: H314 Causes severe skin burns and eye damage. (C >= 70 %; Concentration limits for acute toxicity cannot be translated into GHS from the DSD especially when minimum classifications are given); Skin corrosion/irritation - Skin Corr. 1B:

Product code: HY110 Product name: HYDROGEN Page 12 / 14 PEROXIDE TOPICAL SOLUTION, USP H314 Causes severe skin burns and eye damage. (50 % <= C <70 %; Concentration limits for acute toxicity cannot be translated into GHS from the DSD especially when minimum classifications are given); Skin corrosion/irritation - Skin Irrit. 2: H315 Causes skin irritation. (35 % <= C <50 %; Concentration limits for acute toxicity cannot be translated into GHS from the DSD especially when minimum classifications are given); Serious Eye Damage/Eye Irritation - Eye Dam. 1: H318 Causes serious eye damage. (8 % <= C <50 %; Concentration limits for acute toxicity cannot be translated into GHS from the DSD especially when minimum classifications are given); Serious Eye Damage/Eye Irritation - Eye Irrit. 2: H319 Causes serious eye irritation. (5 % <= C <8 %; Concentration limits for acute toxicity cannot be translated into GHS from the DSD especially when minimum classifications are given); Specific target organ toxicity - Single exposure - STOT SE 3: H335 May cause respiratory irritation. (C >= 35 %; Concentration limits for acute toxicity cannot be translated into GHS from the DSD especially when minimum classifications are given)008-003-00-9

EU - CLP (1272/2008)

R-phrase(s)

R36/38 - Irritating to eyes and skin

S -phrase(s) S28 - After contact with skin, wash immediately with plenty of water S45 - In case of accident or if you feel unwell, seek medical advice immediately (show the label where possible) S 1/2 - Keep locked up and out of the reach of children. S36/39 - Wear suitable protective clothing and eye/face protection

Component CAS No Classification Concentration Safety Phrases Limits: Hydrogen peroxide 7722-84-1 Xn; R20/22 20%<=C C;R34 S: C; R35 5%<=C<20% (1/2)-7-26-28-36/37/39 R5 Xi;R36/38 -45 O; R8

The product is classified in accordance with Annex VI to Directive 67/548/EEC

Indication of danger: Xi - Irritant

Product code: HY110 Product name: HYDROGEN Page 13 / 14 PEROXIDE TOPICAL SOLUTION, USP 16. OTHER INFORMATION

Preparation Date: 7/28/2015 Revision date 8/1/2019 Prepared by: Sonia Owen

Disclaimer: All chemicals may pose unknown hazards and should be used with caution. This Safety Data Sheet (SDS) applies only to the material as packaged. If this product is combined with other materials, deteriorates, or becomes contaminated, it may pose hazards not mentioned in this SDS. The physical properties reported in this SDS are obtained from the literature and do not constitute product specifications. Information contained herein does not constitute a warranty, whether expressed or implied, as to the safety, merchantability or fitness of the goods for a particular purpose. Spectrum Chemicals & Laboratory Products, Inc. assumes no responsibility for results obtained or for incidental or consequential damages, including lost profits, arising from the use of these data. No warranty against infringement of any patent, copyright or trademark is made or implied. It shall be the user's responsibility to develop proper methods of handling and personal protection based on the actual conditions of use. While this SDS is based on technical data judged to be reliable, Spectrum assumes no responsibility for the completeness or accuracy of the information contained herein.

End of Safety Data Sheet

Product code: HY110 Product name: HYDROGEN Page 14 / 14 PEROXIDE TOPICAL SOLUTION, USP

January 08, 2019

Certification of Compliance with current Good Manufacturing Practices

Dear Valued Customer:

Spectrum Chemical Mfg Corp certifies that our USP, NF, FCC, EP, BP, JP, and food grade products are produced, processed, packaged and held in compliance with current Good Manufacturing Practices (cGMP) in accordance with the applicable parts of 21 CFR, parts 210 and 211 and parts 110 and 111 of the Code of Federal Regulations, respectively.

Spectrum is an FDA registered and inspected Drug Establishment. Our United States Food and Drug Administration (USFDA) Registration numbers are as follows:

Spectrum Gardena, California: 2020632 Spectrum New Brunswick, New Jersey: 2246824

Thank you for your interest in Spectrum products. Please feel free to contact me at 310-516-8000, extension 5610 or via email at [email protected] if I may be of further assistance.

Sincerely,

Michael Dang Director, Quality Systems & GMP Compliance

CORPORATE HEADQUARTERS WEST COAST FACILITY

769 Jersey Avenue 14422 South San Pedro Street

New Brunswick, NJ 08901 Gardena, California 90248

PHONE 732.214.1300 PHONE 310.516.8000

FAX 732.246.7132 FAX 310.516.9843

AN ISO 9001:2015 REGISTERED COMPANY www.spectrumchemical.com

July 29, 2019

Certification of Compliance with current Good Manufacturing Practices

Dear Valued Customer:

Spectrum Chemical Mfg Corp certifies that the following product(s) is produced, processed, packaged and held in compliance with current Good Manufacturing Practices (cGMP) in accordance with the applicable parts of 21 CFR, parts 210 and 211 of the Code of Federal Regulations.

Catalog Number Product Name HY110 Hydrogen Peroxide Topical Solution, USP

Spectrum is an FDA registered and inspected Drug Establishment. Our United States Food and Drug Administration (USFDA) Registration numbers are as follows:

Spectrum-Gardena, CA: 2020632 Spectrum-New Brunswick, NJ: 2246824 Spectrum-Shanghai, China: 03006174778

Thank you for your interest in Spectrum products. If we may be of further assistance, please feel free to contact the Quality Assurance department at 310-516-8000 or via email at [email protected]

Sincerely,

Oralia Chavez Quality Assurance Specialist

June 13, 2016

Re: Hydrogen Peroxide Topical Solution, USP- HY110

To Whom It May Concern:

Thank you for your interest in Spectrum high quality chemicals.

We at Spectrum Chemical Mfr. Corp. understand the concern regarding the presence of allergens in raw materials. Please be assured that the following chemical does not contain (Milk; Egg; Fish; Shellfish; Tree nuts; Wheat; Peanuts; Soy; Cereals containing Gluten; Celery; Mustard; Sesame Seed).

Hydrogen Peroxide Topical Solution, USP- HY110

If you have any further questions, please contact Tech Services at (310) 516- 8000 Extension 5471, or by email at [email protected].

Sincerely,

Darlene Dagdag-Lyudmirskiy Technical Services Spectrum Chemical Mfr. Corp.

This document has been produced electronically and is valid without a signature

Certificate Of Analysis

Item Number HY110 Lot Number 1IG0013

Item Hydrogen Peroxide Topical Solution, USP Manufacturer Lot A29441

CAS Number 7722-84-1 Manufacturer Code 1441

Molecular Formula H2O2 Molecular Weight 34.01

Test Specification Result min max

&88&> -242 2.5 3.5 % 3.0 % &(.).9> TO PASS TEST PASSES TEST 343;41&9.1*7*8.):* \[ 0.15 % <0.15 % '&7.:2 TO PASS TEST PASSES TEST *1*2*39&1.25:7.9.*8 . 9.3 8S AS REPORTED <390 μg/g 1.2.94+57*8*7;&9.;*8 0.05 % <0.05 % .)*39.+.(&9.43 TO PASS TEST PASSES TEST *=5.7&9.43)&9* 31-JAN-2021 )&9*4+2&3:+&(9:7* 01-FEB-2018 CLEAR &55*&7&3(* COLORLESS LIQUID 7*8.):&1841;*398 NO RESIDUAL TO PASS TEST SOLVENTS USED

Spectrum Chemical Mfg Corp 14422 South San Pedro Street Gardena 90248 CA

All pharmaceutical ingredients are tested using current edition of applicable pharmacopeia.

Read and understand label and SDS before handling any chemicals. All Spectrum's chemicals are for manufacturing, processing, repacking or research purposes by experienced personnel only. It is the customer's responsibility to provide adequate hazardous material training and ensure that appropriate Personal Protective Equipment (PPE) is used before handling any chemical.

The Elemental Impurities standards implemented by USP and other Pharmaceutical Compendia reflect a growing understanding of the toxicology of trace levels of elemental impurities that can remain in drug substances originating from either raw materials or manufacturing processes. Identifying and quantifying impurities can be critical to predicting the best possible patient outcomes. Elemental Impurities has been a requirement of all products meeting USP/NF, EP and BP monographs since January 1, 2018. More information can be found in USP sections <232> Elemental Impurities – Limits and <233> Elemental Impurities – Procedures. Data for drug substances furnished by Spectrum Chemical Mfg. Corp can be used to ensure that patient daily exposures by oral administration to the selected elements are not exceeded in the formulation of pharmaceutical products.

Item Number HY110 Lot Number 2IE0220

Item Hydrogen Peroxide Topical Solution, USP Manufacturer Lot A30471

CAS Number 7722-84-1 Manufacturer Code 1441

Molecular Formula H2O2 Molecular Weight 34.01

Test Specification Result min max

&88&> -242 2.5 3.5 % 3.0 % &(.).9> TO PASS TEST PASSES TEST 343;41&9.1*7*8.):* \[ 0.15 % <0.15 % '&7.:2 TO PASS TEST PASSES TEST *1*2*39&1.25:7.9.*8 . 9.3 8S AS REPORTED <390 ug/g 1.2.94+57*8*7;&9.;*8 0.05 % <0.05 % .)*39.+.(&9.43 TO PASS TEST PASSES TEST *=5.7&9.43)&9* 28-FEB-2021 )&9*4+2&3:+&(9:7* 01-FEB-2018 CLEAR &55*&7&3(* COLORLESS LIQUID 7*8.):&1841;*398 NO RESIDUAL TO PASS TEST SOLVENTS USED

Spectrum Chemical Mfg Corp 755 Jersey Avenue New Brunswick 08901 NJ

All pharmaceutical ingredients are tested using current edition of applicable pharmacopeia.

Spectrum Chemical Mfg. Corp. repackages Active Pharmaceutical Ingredient chemicals provided by other manufacturers and suppliers. For traceability purposes, Spectrum's Certificate of Analysis contains an identifier code unique to each manufacturer or supplier, as well as the chemical's lot number provided on the original manufacturer Certificate of Analysis. Test results for the original Certificate of Analysis are available upon request from your Spectrum Sales Representative or by calling Spectrum's Quality Department at 1-800-772-8786. L Exp. Date: 03-31-2025 732.214.1300 New Brunswick, NJ 08901 769 Jersey Ave. Headquarters: Corporate accuracy andconcisehazardcommunication. agenciesinordertoensurecompliance, and DrugAdministration(FDA)othergovernmentregulatory Labelling ofChemicals(GHS),aswelltheOccupationalSafetyandHealthAdministration(OSHA),Food specialists stayabreastofthelatestrequirementsGloballyHarmonizedSystemforClassificationand The Spectrumlabelpresentstechnicalandsafetyinformationinaneasilyunderstoodformat.Our A D O C B A E

Label Legend storing hazardouschemicals. the customertocheckwiththeirlocalfiredepartmentforpossibleconflicts withourrecommendationswhen stated,basedonthecolorcodesindicatedtoright.However,unless otherwise itistheresponsibilityof Society forChemicalHazardCommunication(SCHC).Itisrecommended thatlikecolorsbestoredtogether, The criteriausedtoassignbandcolorshavebeenestablishedbythe Storage Codeworkinggroupofthe This color-coded bandindicatesthehazardmostlikelytobeposedbythatmaterialunderstorageconditions. Storage ColorBand

Item Name,Form,Grade Product CatalogNumber Information Warning, SafetyDataandPrecautionary GHS HazardPictograms Bar Code *49452HY110062233fya*

Get medicalattention. before reuse. If skinirritationoccurs: off contaminated clothing andwash it SKIN: Washwithplentyofwater.Take persists: Getmedicalattention.IFON do. Continuerinsing.If eye irritation to easy present and contact lenses,if with waterforseveralminutes.Remove Rinsecautiously : IFINEYES: FIRST AID handling. and anyexposed skin thoroughlyafter face protection •Wash face, hands • Wear protective gloves, eye protection, Causes skinirritation. • Causesseriouseyeirritation WARNING Spect C KEEP FROMCHILDREN

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February 1, 2019

RE: Lot Numbering System

Dear Valued Customer:

This letter is to inform you of Spectrum Chemicals and Laboratory Products’ Lot Numbering System. The system is based on an alpha-numerical sequence which provides the month, year and location of production.

The lot numbering system utilized until 2010 is a sequence of six characters, two letters followed by four numbers. The first letter represents the year, for example, Y denotes 2009 and Z denotes 2010. The second letter represents the month and site, for example, A-L denotes January through December at Spectrum’s Gardena, CA facility, while M-X denotes January through December at the New Brunswick, NJ facility. The following four numbers are sequentially assigned. Example: ZI0928 = The 928th material produced in California in September 2010

The lot numbering system utilized for 2011 and forward, is a sequence of seven characters. The first character, a number, represents the production facility:

1 = Gardena, CA Facility 2 = New Brunswick, NJ Facility 3 = China Facility 4 = Pharmacy, NJ Facility

The second character, a letter, represents the year. For example, A denotes 2011 and B denotes 2012. The third character, a letter, represents the month, with A denoting January and L denoting December. The following four numbers are sequentially assigned.

Example: 2AA0706 = The 706th material produced in New Jersey in January 2011

Thank you for your interest with Spectrum products. Please feel free to contact us at 310-516-8000 or via email at [email protected] if we may be of further assistance.

Sincerely,

Howard Lau, Quality Assurance Specialist

CORPORATE HEADQUARTERS WEST COAST FACILITY 769 Jersey Avenue 14422 South San Pedro Street

New Brunswick, NJ 08901 Gardena, California 90248

PHONE 732.214.1300 PHONE 310.516.8000

FAX 732.246.7132 FAX 310.516.9843

AN ISO 9001:2015 REGISTERED COMPANY www.spectrumchemical.com

Stability – Shelf Life Guidance

Product Covered: HY110, Hydrogen Peroxide Topical Solution, USP

Spectrum Chemical’s manufacturing partner has assigned the following shelf life guidance for the product listed above.

The product, HY110, Hydrogen Peroxide Topical Solution, USP, is assigned a 36 months shelf life from date of manufacturing. The quality and integrity of the chemical depends on the handling and storage conditions. Please refer to the Safety Data Sheet for proper storage and handling procedures.

Adan R. Hernandez Quality Control Manager

Corporate Headquarters 769 Jersey Avenue New Brunswick, NJ 08901-3605

29.July.2019

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