Label: HYVEE COMPLETE CARE FRESH 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

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  • ACTIVE INGREDIENT

    SODIUM FLUORIDE 0.02% (0.01% W/V FLUORIDE ION)

    PURPOSE

    ANTIGINGIVITIS/ANTIPLAQUE

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  • USES

    TO HELP REDUCE AND PREVENT PLAQUE, GINGIVITIS.

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  • WARNINGS

    DO NOT USE IN CHILDREN UNDER 12 YEARS OF AGE.

    KEEP OUT OF REACH OF CHILDREN.

    IF MORE THAN USED FOR RINSING IS ACCIDENTALLY INGESTED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

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  • DIRECTIONS

    RINSE FULL STRENGTH FOR 30 SECONDS WITH 20 ML (2/3 FLUID OUNCE OR 4 TEASPOONFULS) MORNING AND NIGHT. DO NOT SWALLOW.

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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 (AQUA), SORBITOL, ALCOHOL (21.6%), POLOXAMER 407, SODIUM LAURYL SULFATE, EUCALYPTOL, FLAVOR, METHYL SALICYLATE, THYMOL, PHOSPHORIC ACID, SUCRALOSE, MENTHOL, DISODIUM PHOSPHATE, RED 40 (CI 16035), BLUE 1 (ci 42090).

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  • QUESTIONS OR COMMENTS?

    1-800-289-8343

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  • LABEL COPY
  • INGREDIENTS AND APPEARANCE
    HYVEE  COMPLETE CARE FRESH MINT
    sodium fluoride liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:42507-552
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 0.2 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    SORBITOL  
    ALCOHOL  
    POLOXAMER 407  
    SODIUM LAURYL SULFATE  
    EUCALYPTOL  
    METHYL SALICYLATE  
    THYMOL  
    PHOSPHORIC ACID  
    SUCRALOSE  
    MENTHOL  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS  
    FD&C RED NO. 40  
    FD&C BLUE NO. 1  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:42507-552-34 1000 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(42507-552)
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