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 09/13

If you are a consumer or patient please visit this version.

  • 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 RINSING 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:

    WATER, SORBITOL, PROPYLENE GLYCOL, SODIUM PHOSPHATE, POLYSORBATE 20, FLAVOR, POLOXAMER 407, SODIUM BENZOATE, POTASSIUM SORBATE, CALICUM DISODIUM EDTA, DISODIUM PHOSPHATE, SODIUM SACCHARIN, CETYLPYRIDINIUM CHLORIDE, MENTHOL, METHYL SALICYLATE, GREEN 3 (CI 42053), 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 LABEL Item Code (Source) NDC:42507-554
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 0.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    SORBITOL  
    PROPYLENE GLYCOL  
    SODIUM PHOSPHATE  
    POLYSORBATE 20  
    POLOXAMER 407  
    SODIUM BENZOATE  
    POTASSIUM SORBATE  
    EDETATE CALCIUM DISODIUM ANHYDROUS  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS  
    SACCHARIN SODIUM  
    CETYLPYRIDINIUM CHLORIDE  
    MENTHOL  
    METHYL SALICYLATE  
    FD&C GREEN NO. 3  
    FD&C YELLOW NO. 5  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:42507-554-16 474 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part355 09/12/2013
    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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