Label: HYVEE ANTICAVITY MINT- sodium fluoride liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 November 30, 2015

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  • Active ingredient

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

    Purpose

    Antigingivitis/Antiplaque

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  • Uses

    aids in the prevention of dental cavities

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  • 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.

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  • 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.
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  • Other information

    • Store at room temperature
    • Cold weather may cloud this product. Its antiseptic properties are not affected.
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  • 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).

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  • Questions or comments?

    1-800-289-8343

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  • Label Copy
  • INGREDIENTS AND APPEARANCE
    HYVEE  ANTICAVITY MINT
    sodium fluoride liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:42507-554
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:42507-554-17 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part355 11/29/2015
    Labeler - HYVEE INC. (006925671)
    Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
    Establishment
    Name Address ID/FEI Business Operations
    APOLLO HEALTH AND BEAUTY CARE 201901209 manufacture(42507-554)
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