HYVEE ANTISEPTIC ORIGINAL (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) LIQUID [HYVEE INC]

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HYVEE ANTISEPTIC ORIGINAL (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) LIQUID [HYVEE INC]
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NDC 42507-556-34
Set ID 44d77541-d6e2-4bd8-997d-53913bff975f
Category HUMAN OTC DRUG LABEL
Packager HYVEE INC
Generic Name
Product Class
Product Number
Application Number PART356
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  • ACTIVE INGREDIENTS

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

    PURPOSE

    ANTIPLAQUE/ANTIGINGIVITIS

  • USES

    TO HELP REDUCE AND PREVENT PLAQUE AND GINGIVITIS.

  • 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.

  • DIRECTIONS

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

  • OTHER INFORMATION

    STORE AT ROOM TEMPERATURE. COLD WEATHER MAY CLOUD THIS PRODUCT. ITS ANTISEPTIC PROPERTIES ARE NOT AFFECTED.

  • INACTIVE INGREDIENTS:

    WATER (AQUA), ALCOHOL (26.9%), BENZOIC ACID, POLOXAMER 407, SODIUM BENZOATE, CARAMEL.

  • QUESTIONS OR COMMENTS?

    1-800-289-8343

  • LABEL COPY

    IMAGE OF THE LABEL

  • INGREDIENTS AND APPEARANCE
    HYVEE  ANTISEPTIC ORIGINAL
    eucalyptol, menthol, methyl salicylate, thymol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42507-556
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    EUCALYPTOL (UNII: RV6J6604TK) (EUCALYPTOL - UNII:RV6J6604TK) EUCALYPTOL0.92 mg  in 1 mL
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.42 mg  in 1 mL
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE0.60 mg  in 1 mL
    THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E) THYMOL0.64 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CARAMEL (UNII: T9D99G2B1R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42507-556-341000 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35609/12/2013
    Labeler - HYVEE INC (006925671)
    Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    APOLLO HEALTH AND BEAUTY CARE201901209manufacture(42507-556)
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