Label: KROGER KIDS ANTICAVITY FLUORIDE MIXED BERRY- sodium fluoride liquid

  • Category: HUMAN OTC DRUG LABEL

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 23, 2017

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  • Active ingredient

    Sodium fluoride 0.02% (0.01% w/v fluoride ion)

    Purpose

    Anticavity

  • Use

    • Aids in the prevention of dental cavities.
  • Warnings

    Keep out of reach of children.

    • If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center immediately.
  • Directions

    • ​Adults and children 6 years of age and older:
    • ​use twice daily after brushing your teeth with a toothpaste
    • vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out
    • do not swallow the rinse
    • do not eat or drink for 30 minutes after rinsing
    • instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
    • supervise children as necessary until capable of using without supervision
    • ​Children under 6 years of age: consult a dentist or doctor
  • Other information

    • Store at controlled room temperature 20°-25°C (68°-77°F)
    • Cold weather may cloud this product.
  • Inactive ingredients

    Water (Aqua), Xylitol, Glycerin, Zinc Chloride, Benzoic Acid, Flavor (Aroma), Methylparaben.

  • Questions or Comments?

    1-800-632-6900

  • Label Copy

    Image of the label

  • INGREDIENTS AND APPEARANCE
    KROGER KIDS ANTICAVITY FLUORIDE  MIXED BERRY
    sodium fluoride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-563
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.2 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    XYLITOL (UNII: VCQ006KQ1E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ZINC CHLORIDE (UNII: 86Q357L16B)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:30142-563-16500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/20/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35501/20/2017
    Labeler - The Kroger Company (006999528)
    Registrant - Apollo Health and Beauty Care Inc. (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apollo Health and Beauty Care Inc.201901209manufacture(30142-563)
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