Label: COLGATE PHOS-FLUR ORTHO DEFENSE ALCOHOL FREE ANTICAVITY GUSHING GRAPE FLUORIDE- sodium fluoride rinse

  • NDC Code(s): 0126-0034-46
  • Packager: Colgate Oral Pharmaceuticals, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 12, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Sodium fluoride 0.04% (0.02% w/v fluoride ion)

  • Purpose

    Anticavity

  • Use

    aids in the prevention of dental cavities

  • Warnings

    Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    adults and children 6 years of age and older
    • use once a day after brushing your teeth with a toothpaste
    • vigorously swish 10 milliliters (10 mL mark on cap or 2 teaspoonfuls) of rinse between your teeth for 1 minute then spit out
    • do not swallow the rinse
    • do not eat or drink for 30 minutes after rinsing
    • instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
    • supervise children as necessary until capable of using without supervision
    children under 6 years of age
    • ask a dentist or physician
  • Inactive ingredients

    water, sorbitol, sodium phosphate, flavor, potassium sorbate, phosphoric acid, polysorbate 20, FD&C blue no. 1, FD&C red no. 40

  • Other Information

    store at controlled room temperature 68 – 77° F (20 – 25°C)

  • Questions?

    1-800-468-6502

  • SPL UNCLASSIFIED SECTION

    Dist. by:
    COLGATE-PALMOLIVE COMPANY
    New York, NY 10022

  • PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label

    ALCOHOL FREE*

    Colgate®

    Phos•Flur®

    Ortho Defense®

    Anticavity Fluoride Rinse
    Sodium Fluoride Acidulated Phosphate Solution

    IDEAL PROTECTION
    WHILE WEARING BRACES

    ✓
    ORTHODONTIST RECOMMENDED
    ✓
    HELPS STRENGTHEN ENAMEL
    ✓
    HELPS PREVENT CAVITIES

    GUSHING GRAPE

    16.9 FL OZ (1.05 PT) 500 mL

    IMPORTANT: Read directions for proper use

    ADA
    Accepted
    American
    Dental
    Association ®

    P9910320

    Principal Display Panel - 500 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    COLGATE PHOS-FLUR ORTHO DEFENSE ALCOHOL FREE ANTICAVITY GUSHING GRAPE FLUORIDE 
    sodium fluoride rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0126-0034
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION2 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    SODIUM PHOSPHATE (UNII: SE337SVY37)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Product Characteristics
    ColorPURPLEScore    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0126-0034-46500 mL in 1 BOTTLE; Type 0: Not a Combination Product02/15/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM02102/15/2011
    Labeler - Colgate Oral Pharmaceuticals, Inc. (968801118)
    Registrant - Colgate-Palmolive Company (001344381)
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