Label: BIOTENE- sodium monofluorophosphate paste

  • NDC Code(s): 0135-0577-01
  • Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 15, 2023

If you are a consumer or patient please visit this version.

View All Sections
  • 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

    • adults and children 2 years of age and older:
      • apply toothpaste onto a toothbrush
      • 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.
      • 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

    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)
  • INGREDIENTS AND APPEARANCE
    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)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!