Label: HYVEE ANTISEPTIC MINT- eucalyptol, menthol, methyl salicylate and thymol liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 03/14

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  • ACTIVE INGREDIENTS

    EUCALYPTOL 0.092%, MENTHOL 0.042%, METHYL SALICYLATE 0.060%, THYMOL 0.064%

    PURPOSE

    ANTIPLAQUE/ANTIGINGIVITIS

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  • USES

    TO HELP REDUCE AND PREVENT PLAQUE AND GINGIVITIS

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  • WARNINGS

    DO NOT USE FOR CHILDREN UNDER 12 YEARS OF AGE

    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

    RINSE FULL STRENGTH FOR 30 SECONS 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), ALCOHOL (21.6%), SORBITOL, FLAVOR, POLOXAMER 407, BENZOIC ACID, SODIUM SACCHARIN, SODIUM BENZOATE, YELLOW 10 (CI 47005), GREEN 3 (CI 42053)

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  • QUESTIONS OR COMMENTS?

    1-800-289-8343

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  • LABEL COPY
  • INGREDIENTS AND APPEARANCE
    HYVEE  ANTISEPTIC MINT
    eucalyptol, menthol, methyl salicylate, thymol liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:42507-158
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    EUCALYPTOL (EUCALYPTOL) EUCALYPTOL 0.92 mg  in 1 mL
    MENTHOL (MENTHOL) MENTHOL 0.42 mg  in 1 mL
    METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE 0.60 mg  in 1 mL
    THYMOL (THYMOL) THYMOL 0.64 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    ALCOHOL  
    SORBITOL  
    POLOXAMER 407  
    BENZOIC ACID  
    SACCHARIN SODIUM  
    SODIUM BENZOATE  
    D&C YELLOW NO. 10  
    FD&C GREEN NO. 3  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:42507-158-51 1500 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part356 03/21/2014
    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(42507-158)
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