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

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 Label Information

Updated January 20, 2022

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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 FINALpart35502/15/2011
    Labeler - Colgate Oral Pharmaceuticals, Inc. (968801118)
    Registrant - Colgate-Palmolive Company (001344381)
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