Label: ANTISEPTIC- eucalyptol, menthol, methyl salicylate, 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 September 10, 2012

If you are a consumer or patient please visit this version.

  • Safety Seal

    SEALED WITH PRINTED NECKBAN FOR YOUR PROTECTION

  • Active Ingredients

    Eucalyptol 0.092%

    Menthol 0.042%

    Methyl salicylate 0.060%

    Thymol 0.064%

  • Purpose

    Antigingivitis, Antiplaque

  • use

    Use helps control plaque that leads to gingivitis

  • Warnings

    Warnings

  • Do not use

    Don't use if you have painful or swollen gums, pus from the gum line, loose teeth or increased spacing between the teeth. See your dentist immediatel. These may be signs of periodontitis, a serious form of gum disease.

  • Stop use and ask a dentist

    Stop use and ask a dentist if gingivitis, bleeding, or redness persists for more than 2 weeks

  • Keep out of reach of children

    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

    Directions

    adults and chldren 12 years of age and older - vigorously swish 20 mL (2/3 FL OZ or 4 teaspoonfuls) between teeth for 30 seconds then spit out; do not swallow

    Children under 12 years of age - consult a dentist or doctor

    • this rinse is not intended to replace brushing or flossing
  • Other information

    Other informationcold weather may cloud this product. Its antiseptic properties are not affected. Store at room temperature (59°-77°F).

  • Inactive ingredients

    Inactive ingredients water, alcohol 26.9%, benzoic acid, poloxamer 407, sodium benzoate, caramel

  • ADA Council Statement

    The ADA Council on Scientific Affairs Acceptance of Hy-Vee original antiseptic mouth rinse is based on its finding that te product is effective in helping prevent and reduce gingivitis and plaqua above the gumlime, when used as directed.

  • Disclaimer

    This product is not manufactured or distributed by Johnson + Johnson Healthcare products, distributor of Listerine

  • Adverse Reaction

    DISTRIBUTED BY HY-VEE, INC

    5820 WESTOWN PARKWAY

    WEST DES MOINES, IA 50266

    SATISFACTION GUARANTEED

    OR PURCHASE PRICE REFUNDED

    FOR INFORMATION CALL

    1-800-288-8343

  • Principal Display Panel

    HyVee

    Compare to the active

    ingredients in Listerine

    Oral Rinse

    Antiseptic

    Mouth rinse

    Original

    ADA

    Accepted

    American

    Dental

    Association

    Kills germs that cause

    bad breath, plaque & the

    gum disease gingivitis

    1.5 LITERS (50.7 FL OZ)

    image description

  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC 
    eucalyptol, menthol, methyl salicylate, thymol mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42507-318
    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)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CARAMEL (UNII: T9D99G2B1R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42507-318-861000 mL in 1 BOTTLE, PLASTIC
    2NDC:42507-318-121500 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35608/15/1990
    Labeler - Hy-Vee Inc (006925671)
    Registrant - Vi-Jon (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon790752542manufacture(42507-318)