Label: CREST 24G AND TOOTHBRUSH DENTAL KIT- sodium fluoride kit

  • NDC Code(s): 79940-007-00, 79940-008-00
  • Packager: Formia Airline Supplies Limited
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 31, 2023

If you are a consumer or patient please visit this version.

  • Drug Facts

  • Active Ingredient

    Sodium fluoride 0.243% (0.16% w/v fluoride ion)

    Purpose

    Acticavity

  • Use

    toothpate helps protect against cavities

  • Warning

    Keep out of reach of children

    under 6 yrs. 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 yrs. & older: brush teeth thoroughly after meals or at least twice a day or use as dentist-directed
    • do not swallow
    • to minimize swallowing, use a pea-sized amount in children under 6 
    • supervise children's brushing until good habits are established
    • children under 2 yrs: ask a dentist
  • Inactive Ingredients

    glycerin, hydrated silica, sodium hexametaphosphate, water, PEG-6, flavor, trisodium phosphate, sodium lauryl sulfate, carrageenan, cocamidopropyl betaine, sodium saccharin, PEG-20M, xanthan gum, sucralose, mica, titanium dioxide

  • Product Questions?

    1-800-492-7378

  • Package Labeling: Kit

    KIT label3

  • Package Labeling:24g

    Tube3

  • INGREDIENTS AND APPEARANCE
    CREST 24G AND TOOTHBRUSH DENTAL KIT 
    sodium fluoride kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79940-007
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79940-007-001 in 1 KIT01/15/2021
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 24 g
    Part 1 of 1
    CREST 3D WHITE 
    sodium fluoride paste, dentifrice
    Product Information
    Item Code (Source)NDC:79940-008
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.6 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    HEXASODIUM HEXAMETAPHOSPHATE (UNII: N40N91DW96)  
    WATER (UNII: 059QF0KO0R)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    POLYETHYLENE OXIDE 900000 (UNII: 16P9295IIL)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    MICA (UNII: V8A1AW0880)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79940-008-0024 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02101/15/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02101/15/2021
    Labeler - Formia Airline Supplies Limited (668098317)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Procter & Gamble Manufacturing Company017745779manufacture(79940-007)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lianjiang Xiangheng Travel Bag Co.,Ltd.421286135pack(79940-008)