BIOTENE FRESH MINT ORIGINAL- sodium monofluorophosphate paste BIOTENE- sodium monofluorophosphate paste GlaxoSmithKline Consumer Healthcare Holdings (US) LLC 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. ------Drug Facts
Active ingredient(Fresh Mint Original) Sodium monofluorophosphate (0.14% w/v fluoride ion)
Active ingredient (Gentle Mint) Sodium monofluorophosphate 0.76% (0.14% w/v fluoride ion)
Purpose Anticavity
Use aids in the prevention of dental cavities.
Warnings(Fresh Mint Original)
Keep out of reach of children 12 years and under. If you accidentally swallow more than used for brushing, get medical help or contact a Poison Control Center right away. If symptoms of a dry mouth persist, consult a healthcare professional.
Warnings(Gentle Mint)
When using this product, if irritation occurs discontinue use.
Keep out of reach of children under 6 years of age. If more than used for bushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Directions (Fresh Mint Original) Adults and children over 12 years
• apply toothpaste onto a soft bristle toothbrush • brush thoroughly after meals or at least twice a day or use as directed by a dentist or physician.
Children 12 years and under ask a dentist or physician. Once recommended, to minimize swallowing for children under 6, use a pea-sized amount and supervise brushing until good habits are established. Directions (Gentle Mint)
• adults and children 2 years of age and older:
o apply toothpaste onto a toothbrush o brush teeth thoroughly, preferable after each meal or at least twice a day, and not more than 3 times a day, or as directed by a dentist or doctor. Minimizing swallowing. Spit out after brushing. o to minimize swallowing for children under 6 years of age, use a pea-sized amoun and supervise brushing and rinsing until good habits are established.
• children under 2 years of age: Consult a dentist or doctor.
Other information store at or below 25ºC (77ºF)
Inactive ingredients (Fresh Mint Original) Sorbitol, Glycerin, Calcium Pyrophosphate, Water, Hydrated Silica, Xylitol, Silica, Hydroxyethylcellulose, Isoceteth-20, Cellulose Gum, Flavor, Sodium Benzoate, Lactoperoxidase, Potassium Thiocyanate, glucose Oxidase, Lysozyme, Lactoferrin, Calcium Lactate. Contains milk and egg derivatives.
Inactive ingredients (Gentle Mint) sorbitol, hydrated silica, glycerin, calcium pyrophosphate, water, xylitol, silica, hydroxyethylcellulose, isoceteth-20, cellulose gum, flavor, sodium benzoate, calcium lactate.
Questions or comments? Call toll-free 1-800-922-5856
Principal Display Panel (Fresh Mint Original) NDC 0135-0487-01 biotene® Protein-Enzyme System DRY MOUTH FLUORIDE TOOTHPASTE Gentle, Low Foaming Formula Formulated to Not Irritate a Dry Mouth FRESH MINT ORIGINAL NET WT 4.5 OZ (127.6g) #1 RECOMMENDED DRY MOUTH BRAND Helps Maintain Oral Environment
• Helps Prevent Cavities Helps Prevent Cavities • Formulated to Not Irritate a Dry Mouth • Detergent Free (No SLS) • Low Foaming, Mild Flavor • Freshens Bad Breath
#1 Dentist & Hygienist Recommended Brand for Dry Mouth You may not realize you suffer from dry mouth symptoms until it causes dental problems. If you are experiencing some of the following problems, it may be due to a dry mouth.
• Constant dry feeling • Sore or bleeding gums • Cracked lips • Bad breath • Cavities
Dry mouth is commonly associated with the use of medications. Over 400 commonly used drugs may reduce your saliva flow. Biotene® Dry Mouth Toothpaste contains beneficial enzymes found in saliva and helps dry mouth sufferers maintain the oral environment and good oral hygiene. This product contains no saccharin. No sodium lauryl sulfate (SLS) BIOTENE and LP3 are trademarks of the GlaxoSmithKline group of companies. XYLITOL is a registered trademark of Danisco Sweetners Oy. www.biotene.com Naturally Sweetened with Xylitol® Distributed by: GlaxoSmithKline Consumer Healthcare, L.P. Moon Township, PA 15108 ©2011 GlaxoSmithKline 100939XA Principal Display Panel NDC 0135-0577-01 biotene® Fluoride Toothpaste #1 DENTIST RECOMMENDED DRY MOUTH BRAND GENTLE MINT GENTLE FORMULA NET WT 4.3 OZ (121.9g) #1 DENTIST RECOMMENDED DRY MOUTH BRAND SPECIALLY FORMULATED TO NOT IRRITATE & HELPS MAINTAIN A HEALTHY ORAL ENVIRONMENT
• Helps freshen breath • SLS free* • Gentle formula • Essential fluoride toothpaste protection
Also look for other biotene® products including biotene® Oral Rinse, biotene® Oralbalance® Gel and biotene® Mouth Spray *This product contains no Sodium Lauryl Sulfate (SLS) Trademarks are owned by or licensed to the GSK group of companies. Distributed by: GSK Consumer Healthcare Warren, NJ 07059 ©2015 GSK group of companies or its licensor. All rights reserved. 105172XB
BIOTENE FRESH MINT ORIGINAL sodium monofluorophosphate paste
Product Information Product T ype HUMAN OTC DRUG Ite m Code (Source ) NDC:0 135-0 48 7 Route of Administration ORAL
Active Ingredient/Active Moiety Basis of Ingredient Name Strength Strength SO DIUM MO NO FLUO RO PHO SPHATE (UNII: C8 10 JCZ56 Q) (FLUORIDE ION - 1.4 mg FLUORIDE ION UNII:Q8 0 VPU40 8 O) in 1 g
Inactive Ingredients Ingredient Name Strength SO RBITO L (UNII: 50 6 T6 0 A25R) GLYCERIN (UNII: PDC6 A3C0 OX) CALCIUM PYRO PHO SPHATE (UNII: X6 9 NU20 D19 ) WATER (UNII: 0 59 QF0 KO0 R) HYDRATED SILICA (UNII: Y6 O7T4G8 P9 ) XYLITO L (UNII: VCQ0 0 6 KQ1E) SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4) HYDRO XYETHYL CELLULO SE (14 0 MPA.S AT 5%) (UNII: 8 136 Y38 GY5) CETETH-2 0 (UNII: I8 35H2IHHX) CARBO XYMETHYLCELLULO SE SO DIUM, UNSPECIFIED FO RM (UNII: K6 79 OBS311) SO DIUM BENZO ATE (UNII: OJ245FE5EU) LACTO PERO XIDASE BO VINE (UNII: 0 1UIN5OC49 ) PO TASSIUM THIO CYANATE (UNII: TM72138 6 4A) GLUCO SE O XIDASE (UNII: 0 T8 39 2U5N1) LYSO ZYME, CHICKEN EGG WHITE (UNII: 1ZML0 31Y3C) TALACTO FERRIN ALFA (UNII: 7A0 55A9 QRR) CALCIUM LACTATE (UNII: 2URQ2N32W3)
Product Characteristics Color WHITE Score Shape Siz e Flavor MINT (Fresh Mint) Imprint Code Contains
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0 135-0 48 7-0 1 1 in 1 CARTON 0 4/18 /20 11 1 127.6 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct 2 NDC:0 135-0 48 7-0 2 1 in 1 CARTON 0 4/18 /20 11 2 21.3 g in 1 TUBE; Type 0 : No t a Co mbinatio n 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 part355 0 4/18 /20 11
BIOTENE sodium monofluorophosphate paste
Product Information Product T ype HUMAN OTC DRUG Ite m Code (Source ) NDC:0 135-0 577 Route of Administration ORAL
Active Ingredient/Active Moiety Basis of Ingredient Name Strength Strength SO DIUM MO NO FLUO RO PHO SPHATE (UNII: C8 10 JCZ56 Q) (FLUORIDE ION - 1.4 mg FLUORIDE ION UNII:Q8 0 VPU40 8 O) in 1 g
Inactive Ingredients Ingredient Name Strength SO RBITO L (UNII: 50 6 T6 0 A25R) HYDRATED SILICA (UNII: Y6 O7T4G8 P9 ) CALCIUM PYRO PHO SPHATE (UNII: X6 9 NU20 D19 ) GLYCERIN (UNII: PDC6 A3C0 OX) WATER (UNII: 0 59 QF0 KO0 R) XYLITO L (UNII: VCQ0 0 6 KQ1E) SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4) HYDRO XYETHYL CELLULO SE (14 0 MPA.S AT 5%) (UNII: 8 136 Y38 GY5) ISO CETETH-2 0 (UNII: O0 20 0 6 5R7Z) CARBO XYMETHYLCELLULO SE SO DIUM, UNSPECIFIED FO RM (UNII: K6 79 OBS311) SO DIUM BENZO ATE (UNII: OJ245FE5EU) CALCIUM LACTATE (UNII: 2URQ2N32W3)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0 135-0 577-0 1 1 in 1 CARTON 0 9 /0 1/20 16 1 121.9 g in 1 TUBE; Type 0 : No t a Co mbinatio n 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 part355 0 9 /0 1/20 16
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
Revised: 3/2017 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC