KROGER COOL MINT BOOST MOUTH (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) RINSE [THE KROGER COMPANY]

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KROGER COOL MINT BOOST MOUTH (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) RINSE [THE KROGER COMPANY]
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NDC 30142-978-33
Set ID 24ad0af2-8694-4bf1-8cfd-0b43ba4514b5
Category HUMAN OTC DRUG LABEL
Packager The Kroger Company
Generic Name
Product Class
Product Number
Application Number PART356
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  • Active ingredients

    Eucalyptol 0.92%, Menthol 0.042%, Methyl Salicylate 0.060%, Thymol 0.064%

    Purpose

    Antigingivitis, Antiplaque

  • Uses

    helps control plaque that leads to gingivitis, an early form of gum disease.

  • Warnings

    Stop use and ask a dentist if

    • gingivitis, bleeding, or redness persists for more than 2 weeks.
    • you have painful or swollen gums, pus from the gum line, loose teeth, increasing space between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.

    Keep out of reach of children under 6 years of age.

    If more than used for rinsing is accidentally ingested, get medical help or contact a Poison Control Center immediately.

  • Directions

    Adults and children 12 years of age and older: vigorously swish 20 milliliters of rinse between your teeth twice a day for 30 seconds and then spit out. Do not swallow

    Children 6 years to under 12 years of age: supervise use.

    Children under 6 years of age: do not use

  • Other information

    • this rinse is not intended to replace brushing or flossing.
    • store at room temperature.
    • cold weather may cloud this product. Its antiseptic properties are not affected.
  • Inactive ingredients

    Water (Aqua), Alcohol (21.6%), Poloxamer 407, Flavor, Benzoic Acid, Sodium Saccharin, Sodium Benzoate, Sucralose, Green 3 (CI 42053).

  • Questions or comments?

    1-800-632-6900

  • Label Copy

    Image of the label

  • INGREDIENTS AND APPEARANCE
    KROGER COOL MINT BOOST MOUTH 
    eucalyptol, menthol, methyl salicylate, thymol rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-978
    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 SALICYLATE0.6 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)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:30142-978-331000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/14/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35602/14/2018
    Labeler - The Kroger Company (006999528)
    Registrant - Apollo Health and Beauty Care Inc. (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apollo Health and Beauty Care Inc.201901209manufacture(30142-978)
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