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

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HYVEE ANTISEPTIC BLUE MINT (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) LIQUID [HYVEE INC]
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NDC 42507-558-50
Set ID da5f2712-b31b-4eeb-a8ee-f77fb9d07239
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
    • gingivitis
  • Warnings

    Do not use in children under 6 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 (21.6%), Sorbitol Solution, Flavor, Poloxamer 407, Benzoic Acid, Sodium Saccharin, Sodium Benzoate, Green 3 (CI 42053)

  • Questions or comments?

    1-800-289-8343

  • Label Copy

    Image of the label

  • INGREDIENTS AND APPEARANCE
    HYVEE  ANTISEPTIC BLUE MINT
    eucalyptol, menthol, methyl salicylate, thymol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42507-558
    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)  
    SORBITOL (UNII: 506T60A25R)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42507-558-501500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35608/09/2015
    Labeler - HYVEE INC (006925671)
    Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    APOLLO HEALTH AND BEAUTY CARE201901209manufacture(42507-558)
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