BIOTENE- sodium monofluorophosphate paste 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

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Drug Facts

Active ingredient

Sodium monofluorophosphate 0.76% (0.14% w/v fluoride ion)

Purpose

Anticavity

Use

aids in the prevention of dental cavities.

Warnings

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

Other information

store at or below 25ºC (77ºF)

Inactive ingredients

sorbitol, glycerin, calcium pyrophosphate, water, hydrated silica, xylitol, silica, hydroxyethyl cellulose, isoceteth-20, cellulose gum, flavor, sodium benzoate, sodium lactate.

Questions or comments?

Call toll-free 1-800-922-5856

Additional information

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

@2019 GSK group of companies or its licensor.

Questions or Comments?

1-800-922-5856

Principal Display Panel

NDC 0135-0577-01

biotene®

Fluoride Toothpaste

SPECIALLY FORMULATED TO NOT IRRITATE

Helps prevent cavities & strengthen teeth

Gentle Formula

GENTLE MINT

NET WT 4.3 OZ (121.9g)

1000114 Front Carton

Biotene Gentle Mint Original 4.3 oz (121.9g)
BIOTENE 
sodium monofluorophosphate paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0577
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.4 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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, UNSPECIFIED (UNII: T4V6TWG28D)  
ISOCETETH-20 (UNII: O020065R7Z)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
CALCIUM LACTATE (UNII: 2URQ2N32W3)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0577-011 in 1 CARTON09/01/2016
1121.9 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02209/01/2016
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

Revised: 11/2023
Document Id: 0a3dc8fe-422b-85fa-e063-6294a90ad359
Set id: a47a6502-efb2-4072-9562-cbe293531c2b
Version: 8
Effective Time: 20231115
 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC