DERMAWASH- sulfur soap soap KAVI Skin Solutions, Inc. Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies. ------DermaWash

Dosage & Administration Directions for Use: 1. Rinse face and/or body with warm water. 2. Dispense 1 to 2 pumps of cleanser onto palm or washcloth. 3. Rub palms or washcloth together, spreading cleanser evenly and building a lather. 4. Cleanse skin gently but thoroughly. 5. Rinse face and/or body with warm water.

Purpose KAVI DermaWash provides an ideal approach to cleansing normal or combination skin with pH sensitivity. DermaWash utilizes allergy-tested ingredients that are non-comedogenic, pH-balancing, and completely free of animal products. Frequent washing will not cause dryness or irritation, and DermaWash will not aggravate rosacea, eczema, psoriasis, and many varieties of skin allergies. DermaWash is made with colloidal sulfur to enhance the hydrolipidic layer’s acidity and protect skin from bacterial infections. Suitable for use on the face and body, it is easy on the senses and a practical replacement to traditional animal-based soaps. Designed for daily use, DermaWash can also serve as an ideal cleanser for pre-peel preparation of skin.

Indications & Usage DermaWash is best suited for the treatment of acne-prone skin. Directions: 1. Rinse face and/or body with warm water. 2. Dispense 1 to 2 pumps of cleanser onto palm or washcloth. 3. Rub palms or washcloth together, spreading cleanser evenly and building a lather. 4. Cleanse skin gently but thoroughly. 5. Rinse face and/or body with warm water.

Active Ingredients Active Ingredient: colloidal sulfur (1%)

Inactive Ingredients Inactive Ingredients: deionized water, sodium lauryl sulfate, monoalkyl phosphate, triethanolamine, ethylene glycol distearate, sodium laureth sulfate, glycol distearate, cocamide-mea, laureth-10, myristic acid, diethanolamine, lauryl betaine, lauric acid, polysorbate 80, tocopherol acetate, DMDM hydantoin, light fragrance. Warnings For external use only. If swallowed, seek medical attention. Avoid contact with eyes and mucous membranes. In case of eye contact, flush with cold water. Keep out of reach of children.

Keep out of reach of children CAUTION: For external use only. If swallowed, seek medical attention. Avoid contact with eyes and mucous membranes. In case of eye contact, flush with cold water. Keep out of reach of children.

Front and Back Labels KAVI DermaWash provides an ideal approach to cleansing normal or combination skin with pH sensitivity. DermaWash utilizes allergy-tested ingredients that are non-comedogenic, pH-balancing, and completely free of animal products. Frequent washing will not cause dryness or irritation, and DermaWash will not aggravate rosacea, eczema, psoriasis, and many varieties of skin allergies. DermaWash is made with colloidal sulfur to enhance the hydrolipidic layer’s acidity and protect skin from bacterial infections. Suitable for use on the face and body, it is easy on the senses and a practical replacement to traditional animal-based soaps. Designed for daily use, DermaWash can also serve as an ideal cleanser for pre-peel preparation of skin.

Directions: 1. Rinse hands and face with warm water. 2. Dispense 1 to 2 pumps of cleanser onto palm. 3. Rub palms together, spreading cleanser to fingertips. 4. Cleanse face gently but thoroughly. 5. Rinse hands and face with warm water. 6. Repeat as needed. Active Ingredient: colloidal sulfur (1%). Inactive Ingredients: deionized water, sodium lauryl sulfate, monoalkyl phosphate, triethanolamine, ethylene glycol distearate, sodium laureth sulfate, glycol distearate, cocamide-mea, laureth-10, myristic acid, diethanolamine, lauryl betaine, lauric acid, polysorbate 80, tocopherol acetate, DMDM hydantoin, light fragrance. CAUTION: For external use only. If swallowed, seek medical attention. Avoid contact with eyes and mucous membranes. In case of eye contact, flush with cold water. Keep out of reach of children. KAVI Skin Solutions, Inc. San Francisco, CA · www.kaviskin.com DERMAWASH sulfur soap soap

Product Information Product T ype HUMAN OTC DRUG Ite m Code (Source ) NDC:42771-0 0 35 Route of Administration TOPICAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SULFUR (UNII: 70 FD1KFU70 ) (SULFUR - UNII:70 FD1KFU70 ) SULFUR 1 g in 10 0 g

Inactive Ingredients Ingredient Name Strength TRO LAMINE (UNII: 9 O3K9 3S3TK) 7 g in 10 0 g GLYCO L DISTEARATE (UNII: 13W7MDN21W) 3 g in 10 0 g SO DIUM LAURETH SULFATE (UNII: BPV39 0 UAP0 ) 3 g in 10 0 g MYRISTIC ACID (UNII: 0 I3V7S25AW) 2 g in 10 0 g LAURYL BETAINE (UNII: Y4P9 27Q133) 2 g in 10 0 g WATER (UNII: 0 59 QF0 KO0 R) 57.75 g in 10 0 g SO DIUM LAURYL SULFATE (UNII: 36 8 GB5141J) 10 g in 10 0 g

Packaging Marketing Start Marketing End # Item Code Package Description Date Date NDC:42771-0 0 35- 1 g in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n 1 0 3/0 1/20 0 7 1 Pro duct

Marketing Information Marke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date OTC mo no graph final part358 H 0 3/0 1/20 0 7

Labeler - KAVI Skin Solutions, Inc. (179144683)

Revised: 10/2020 KAVI Skin Solutions, Inc.