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BIOTENE Fresh Mint Original by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

Dosage form: paste
Ingredients: SODIUM MONOFLUOROPHOSPHATE 1.4mg in 1g
Labeler: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
NDC Code: 0135-0487

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
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 TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0487
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (FLUORIDE ION) FLUORIDE ION1.4 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL 
GLYCERIN 
CALCIUM PYROPHOSPHATE 
WATER 
HYDRATED SILICA 
XYLITOL 
SILICON DIOXIDE 
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) 
CETETH-20 
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM 
SODIUM BENZOATE 
LACTOPEROXIDASE BOVINE 
POTASSIUM THIOCYANATE 
GLUCOSE OXIDASE 
LYSOZYME, CHICKEN EGG WHITE 
TALACTOFERRIN ALFA 
CALCIUM LACTATE 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorMINT (Fresh Mint) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0135-0487-011 TUBE in 1 CARTON
1127.6 g in 1 TUBE
2NDC:0135-0487-021 TUBE in 1 CARTON
221.3 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35504/18/2011
BIOTENE 
sodium monofluorophosphate paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0577
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (FLUORIDE ION) FLUORIDE ION1.4 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL 
HYDRATED SILICA 
CALCIUM PYROPHOSPHATE 
GLYCERIN 
WATER 
XYLITOL 
SILICON DIOXIDE 
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) 
ISOCETETH-20 
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM 
SODIUM BENZOATE 
CALCIUM LACTATE 
Packaging
#Item CodePackage Description
1NDC:0135-0577-011 TUBE in 1 CARTON
1121.9 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35509/01/2016
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

Revised: 03/2017
 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

← See all BIOTENE Fresh Mint Original brands

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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