Label: BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE WATERMELON- sodium fluoride liquid

  • NDC Code(s): 73928-036-01
  • Packager: Kingkey MBC Life Technology Group Co.,Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 1, 2024

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  • Active ingredient

    SODIUM FLUORIDE 0.05%

  • Puropse

    (0.05% w/v fluoride ion)---------Anticavity

  • Uses

    helps protect teeth against cavities.

  • WARNINGS

  • Warnings

    Keep out of reach of children under 6 years of age. If you accidentally swallow more than used for rinsing, seek professional help or contact a Poison Control Center immediately.

  • Directions

    Adults and children 6 years and older:

    • Use daily after you brush your teeth with toothpaste.
    • Rinse toothpaste from mouth prior to use.
    • Shake well before each use.
    • Twist and remove cap.
    • Rinse or gargle for 30 seconds with 15 ml and spit out
    • Do Not swallow the rinse.
    • Do Not eat or drink for 30 minutes after rinsing.
    • Supervise children as necessary.
    • Children under 6 years of age, consult with a dentist or doctor
  • Inactive ingredients

    WATER
    SORBITOL
    GLYCERIN
    XYLITOL
    POTASSIUM SORBATE
    SODIUM BENZOATE
    PEG-40 HYDROGENATED CASTOR OIL
    FLAVOR
    SODIUM SACCHARIN
    CETYLPYRIDINIUM CHLORIDE

    METHYL DIISOPROPYL PROPIONAMIDE

    SUCRALOSE
    CITRIC ACID

    FD&C Yellow No.5（CI 19140）

    FD&C Blue No.1（CI 42090）

  • Questions or comments?

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  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE WATERMELON 
    sodium fluoride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73928-036
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE0.05 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    METHYL DIISOPROPYL PROPIONAMIDE (UNII: 6QOP5A9489)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    WATER (UNII: 059QF0KO0R)  
    XYLITOL (UNII: VCQ006KQ1E)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73928-036-01355 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2024
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02105/01/2024
    Labeler - Kingkey MBC Life Technology Group Co.,Ltd (545349263)
    Establishment
    NameAddressID/FEIBusiness Operations
    KING KEY MBC LIFE TECHNOLOGY GROUP CO., LTD545349263manufacture(73928-036)
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