Label: COLGATE 5G AND TOOTHBRUSH DENTAL KIT- sodium monofluorophosphate kit

  • NDC Code(s): 79940-004-00, 79940-005-05
  • Packager: Formia Airline Supplies Limited
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 31, 2023

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  • Drug Facts

  • Active ingredient

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

    Purpose

    Anticavity

  • Use

    Aids in the prevention of dental caries

  • Warning

    Keep out of reach of children.

    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 doctor. Instruct children under 6 years of age in good brushing and rinising habits (to minimize swallowing). Supervuse children as necessary until capable of using without supervision.
    • Children under 6 years of age: Consult a dentist or doctor.
  • Inactive ingredients

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

  • Questions or comments?

    1-800-468-6502

  • Package Labeling:Kit

    1

  • Package Labeling:5g

    2

  • INGREDIENTS AND APPEARANCE
    COLGATE 5G AND TOOTHBRUSH DENTAL KIT 
    sodium monofluorophosphate kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79940-004
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79940-004-001 in 1 KIT01/19/2021
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 5 g
    Part 1 of 1
    COLGATE ANTICAVITY 
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Item Code (Source)NDC:79940-005
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79940-005-055 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02101/19/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02101/19/2021
    Labeler - Formia Airline Supplies Limited (668098317)
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