BIOTENE FRESH MINT ORIGINAL- sodium fluoride paste
GlaxoSmithKline Consumer Healthcare LP

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.

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Active ingredient

Sodium Fluoride (0.15% w/v fluoride ion)

Purpose

Anticavity

Use

aids in the prevention of dental cavities

Warnings

Keep out of reach of children 12 years of age 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. Do not use if you are allergic to any of the ingredients.

Directions

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.

Other Information

store below 25°C (77F°)

Inactive Ingredients (Fresh Mint Original)

Water, Sorbitol, Hydrated Silica, Glycerin, PEG-8, Cocamidopropyl Betaine, Xanthan Gum, Flavor, Sodium Saccharin, Sucralose, Titanium Dioxide, Sodium Hydroxide

Questions or comments?

call toll-free 1-800-922-5856 weekdays

Principal Display Panel

NDC 0135-0557-01

biotene®

ESSENTIAL FLUORIDE TOOTH PROTECTION

DRY MOUTH

FLUORIDE TOOTHPASTE

Gentle Formula

Designed to Not Irritate a Dry Mouth

NEW Improved pH Balance

FRESH MINT ORIGINAL

NET WT 4.3 OZ (121.9g)

#1 RECOMMENDED DRY MOUTH BRAND

Helps Maintain Oral Environment

•: Helps Prevent Cavities
•: Designed to Not Irritate a Dry Mouth
•: SLS Free
•: Mild Flavor
•: Helps Freshen Bad Breath

#1 Dentist & Hygienist Recommended Brand for Dry Mouth

If you suffer from dry mouth you may be experiencing some of these problems.

•: Constant dry feeling
•: 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.

With brushing biotene® toothpaste helps maintain a healthy oral environment and provides essential fluoride tooth protection for dry mouth sufferers or for people who need mild toothpaste.

ALWAYS FOLLOW THE LABEL

This product contains no Sodium Lauryl Sulfate (SLS)

biotene and various design elements are trademarks of the GlaxoSmithKline group of companies.

www.biotene.com

Distributed by:

GlaxoSmithKline

Consumer Healthcare, L.P.

Moon Township, PA 15108

102875XA

Biotene Fresh Mint Original 4.3 oz carton

BIOTENE FRESH MINT ORIGINAL
sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0135-0557
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (FLUORIDE ION)	FLUORIDE ION	1.5 mg in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER
SORBITOL
HYDRATED SILICA
GLYCERIN
POLYETHYLENE GLYCOL 400
COCAMIDOPROPYL BETAINE
XANTHAN GUM
SACCHARIN SODIUM
SUCRALOSE
TITANIUM DIOXIDE
SODIUM HYDROXIDE

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

Packaging
#	Item Code	Package Description
1	NDC:0135-0557-01	1 in 1 CARTON
1		121.9 g in 1 TUBE
2	NDC:0135-0557-02	1 in 1 CARTON
2		19.8 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	07/15/2013

Labeler - GlaxoSmithKline Consumer Healthcare LP (828924212)

Revised: 06/2013

Document Id: 1101c17f-c848-4cd5-a7cd-679b59dbe1bf

Set id: 1101c17f-c848-4cd5-a7cd-679b59dbe1bf

Version: 1

Effective Time: 20130624

GlaxoSmithKline Consumer Healthcare LP