Label: COLGATE- sodium fluoride paste

  • 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 December 27, 2021

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  • 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 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 older: brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician


    children 2 to 6 years: use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)


    children under 2 years: ask a dentist or physician

  • Inactive Ingredients

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

  • Questions?

    1-800-468-6502

  • SPL UNCLASSIFIED SECTION

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

  • DRUG FACTS PANEL INSERT

    DRUG FACTS PANEL

  • DENTAL KIT - COLGATE TOOTHPASTE 5g Labels

    TUBE LABELING:

    Colgate5g1

    KIT PACKAGING:

    KIT PACKAGING 5G

  • DENTAL KIT - COLGATE TOOTHPASTE 10g

    TUBE LABELING:

    Colgate10g1

    KIT PACKAGING:

    KIT PACKAGING 10G

  • INGREDIENTS AND APPEARANCE
    COLGATE 
    sodium fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69491-060
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69491-060-451 in 1 BAG12/03/2014
    15 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:69491-060-941 in 1 CARTON12/03/2014
    210 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35512/03/2014
    Labeler - Buzz Export Services Pty., Ltd. (747317902)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Baron Travel Product Co., Ltd.554520509repack(69491-060)
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