HYVEE ANTICAVITY MINT (SODIUM FLUORIDE) LIQUID [HYVEE INC.]

HYVEE ANTICAVITY MINT (SODIUM FLUORIDE) LIQUID [HYVEE INC.]
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NDC 42507-554-17
Set ID 8cca3d39-1df2-4e83-af2b-1f6599dfb27b
Category HUMAN OTC DRUG LABEL
Packager HYVEE INC.
Generic Name
Product Class
Product Number
Application Number PART355
  • Active ingredient

    Sodium Fluoride 0.05% (0.02% w/v Fluoride ion)

    Purpose

    Antigingivitis/Antiplaque

  • Uses

    aids in the prevention of dental cavities

  • Warnings

    Keep out of reach of children

    Keep out of reach of children.

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

  • Directions

    • ​Adults and children 6 years of age and older:
    • ​use once a day after brushing your teeth with toothpaste
    • vigorously swish 10 mL 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
    • 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 room temperature
    • Cold weather may cloud this product. Its antiseptic properties are not affected.
  • Inactive ingredients

    Calcium Disodium EDTA, Cetylpyridinium Chloride, Disodium Phosphate, Flavor, Green 3 (CI 42053), Menthol, Methyl Salicylate, Poloxamer 407, Polysorbate 20, Potassium Sorbate, Propylene Glycol, Sodium Benzoate, Sodium Phosphate, Sodium Saccharin, Sorbitol, Water (Aqua), Yellow 5 (CI 19140).

  • Questions or comments?

    1-800-289-8343

  • Label Copy

    Image of the label

  • INGREDIENTS AND APPEARANCE
    HYVEE  ANTICAVITY MINT
    sodium fluoride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42507-554
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM PHOSPHATE (UNII: SE337SVY37)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    MENTHOL (UNII: L7T10EIP3A)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42507-554-17473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35511/29/2015
    Labeler - HYVEE INC. (006925671)
    Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    APOLLO HEALTH AND BEAUTY CARE201901209manufacture(42507-554)

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