BIOTENE FRESH MINT ORIGINAL- sodium monofluorophosphate paste BIOTENE- sodium monofluorophosphate paste

biotene by

Drug Labeling and Warnings

biotene by is a Otc medication manufactured, distributed, or labeled by Haleon US Holdings LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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
• 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

INGREDIENTS AND APPEARANCE

BIOTENE  FRESH MINT ORIGINAL
sodium monofluorophosphate paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0135-0487
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.4 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
CALCIUM PYROPHOSPHATE (UNII: X69NU20D19)
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
XYLITOL (UNII: VCQ006KQ1E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) (UNII: 8136Y38GY5)
CETETH-20 (UNII: I835H2IHHX)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
SODIUM BENZOATE (UNII: OJ245FE5EU)
LACTOPEROXIDASE BOVINE (UNII: 01UIN5OC49)
POTASSIUM THIOCYANATE (UNII: TM7213864A)
GLUCOSE OXIDASE (UNII: 0T8392U5N1)
LYSOZYME, CHICKEN EGG WHITE (UNII: 1ZML031Y3C)
TALACTOFERRIN ALFA (UNII: 7A055A9QRR)
CALCIUM LACTATE (UNII: 2URQ2N32W3)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor	MINT (Fresh Mint)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0135-0487-01	1 in 1 CARTON	04/18/2011
1		127.6 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 0135-0487-02	1 in 1 CARTON	04/18/2011
2		21.3 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	04/18/2011

BIOTENE 
sodium monofluorophosphate paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0135-0577
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.4 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
CALCIUM PYROPHOSPHATE (UNII: X69NU20D19)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
XYLITOL (UNII: VCQ006KQ1E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) (UNII: 8136Y38GY5)
ISOCETETH-20 (UNII: O020065R7Z)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CALCIUM LACTATE (UNII: 2URQ2N32W3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0135-0577-01	1 in 1 CARTON	09/01/2016
1		121.9 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	09/01/2016

Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)