Label: COLGATE ANTICAVITY- sodium monofluorophosphate paste, dentifrice

  • NDC Code(s): 42555-060-45, 42555-060-94
  • Packager: COLGATE-PALMOLIVE (THAILAND) LIMITED
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 31, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Sodium monofluorophosphate 0.76% (0.15% w/v fluoride ion)

  • Purpose

    Anticavity

  • Use

    helps protect against cavities

  • Warnings

    Keep out of the reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    adults and children 2 years of age and olderbrush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
    children 2 to 6 yearsuse only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
    children under 2 yearsask a dentist or physician
  • Inactive ingredients

    dicalcium phosphate dihydrate, water, sorbitol, sodium lauryl sulfate, flavor, cellulose gum, tetrasodium pyrophosphate, sodium saccharin

  • Questions or comments?

    Call toll-free 1-800-468-6502

  • SPL UNCLASSIFIED SECTION

    Manufactured by:
    COLGATE-PALMOLIVE (THAILAND) Limited,
    Chonburi 20000, Thailand.

  • PRINCIPAL DISPLAY PANEL - 5 g Tube Label

    P1536526_E

    Colgate®
    Anticavity Toothpaste

    Cavity
    Protection

    NET WT 5g(0.17 oz)

    2
    HDPE

    PRINCIPAL DISPLAY PANEL - 5 g Tube Label
  • PRINCIPAL DISPLAY PANEL - 10 g Tube Label

    P1536525

    Colgate®
    Anticavity Toothpaste

    Cavity
    Protection

    NET WT 10g(0.35 OZ)

    2
    HDPE

    PRINCIPAL DISPLAY PANEL - 10 g Tube Label
  • INGREDIENTS AND APPEARANCE
    COLGATE ANTICAVITY 
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42555-060
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION7.6 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42555-060-945 g in 1 TUBE; Type 0: Not a Combination Product06/04/2009
    2NDC:42555-060-4510 g in 1 TUBE; Type 0: Not a Combination Product06/04/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35506/04/2009
    Labeler - COLGATE-PALMOLIVE (THAILAND) LIMITED (672044552)
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