KROGER KIDS ANTICAVITY FLUORIDE MIXED BERRY (SODIUM FLUORIDE) LIQUID [THE KROGER COMPANY]

KROGER KIDS ANTICAVITY FLUORIDE MIXED BERRY (SODIUM FLUORIDE) LIQUID [THE KROGER COMPANY]
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NDC 30142-563-16
Set ID b409c574-67d5-445c-a015-25cf543cb6e4
Category HUMAN OTC DRUG LABEL
Packager The Kroger Company
Generic Name
Product Class
Product Number
Application Number PART355
  • 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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