Label: HANDY SOLUTIONS COOL MINT LISTERINE ANTISEPTIC MOUTHWASH- eucalyptol, menthol, methyl salicylate, and thymol mouthwash

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 November 25, 2019

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  • Handy Solutions Cool Mint LISTERINE ANTISEPTIC MOUTHWASH


  • ACTIVE INGREDIENT

    Active ingredientsPurposes
    Eucalyptol 0.092% }
    Menthol 0.042% }
    Methyl salicylate 0.060% }
    Thymol 0.064% }     		Antiplaque/antigingivitis
  • Uses

    Helps prevent and reduce:

    • plaque
    • gingivitis
  • 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 swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • rinse full strength for 30 seconds with 20 ml (2/3 fluid ounce or 4 teaspoonfuls) morning and right
    • do not swallow
  • Other information

    • store at controlled room temperature 20 degree - 25 degree C (68 degree - 77 degree F)
    • cold weather may cloud this product its antiseptic properties are not affected.
  • Inactive ingredients

    water, alcohol (21.6%),sorbitol solution, flavoring, poloxamer 407,  benzoic acid, sodium saccharin,sodium benzoate, FDandC green no. 3

  • Questions?


    call toll-free 1-888-222-0182. weekdays

  • Handy Solutions Cool Mint LISTERINE ANTISEPTIC MOUTHWASH 95ml (67751-103-01)

    Cool Mint Listerine

  • INGREDIENTS AND APPEARANCE
    HANDY SOLUTIONS COOL MINT LISTERINE ANTISEPTIC MOUTHWASH 
    eucalyptol, menthol, methyl salicylate, and thymol mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67751-103
    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
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    SORBITOL (UNII: 506T60A25R)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67751-103-0195 mL in 1 BOTTLE; Type 0: Not a Combination Product08/21/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35608/21/2013
    Labeler - Navajo Manufacturing Company Inc. (091917799)
    Establishment
    NameAddressID/FEIBusiness Operations
    Navajo Manufacturing Company Inc136941411repack(67751-103) , relabel(67751-103)
    Establishment
    NameAddressID/FEIBusiness Operations
    Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc.801375143manufacture(67751-103)
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