Label: ANTISEPTIC MOUTH RINSE- eucalyptol, menthol, methyl salicylate, thymol mouthwash

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated July 10, 2020

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  • TEP

    Sealed With Printed Neckband For Your Protection

  • Active ingredients

    Eucalyptol, Menthol, Methyl salicylate, Thymol

  • purpose

    Antigingivitis, Antiplaque

  • Use

    helps control plaque that leads to gingvitis

  • Warnings

    for this product

  • Do not use

    if you have painful or swollen gums, pus from the fum line, loose teeth or increased spacing between the teeth.  See your dentist immediately.  These may be signs of periodontitis, a serious form of gum disease.

  • stop use and ask a dentist if

    gingivitis, bleeding, or redness persists for more than 2 weeks

  • 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

    Adults and children 12 years of age and older - vigorously swish 20 ml (2/3 FL OZ or 4 teaspoonfruls) between teeth for 30 seconds than 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 informatin

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

  • inactive ingredients

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

  • ADA Statement

    The ADA Council on Scientific Affairs Acceptance of Care One Antiseptic Mouth Rinse is based on it finding that the product is effective in helping to prevent and reduce gingivitis and plaque above the gumline, wuhen used as directed.

  • Disclaimer

    This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of Listerine.

  • Adverse Reaction

    DISTRIBUTED BY

    AMERICAN SALES COMPANY

    4201 WALDEN AVENUE  LANCASTER, NY 14086

    318.003/318AH

  • princpal display panel

    Compare to

    Listerine

    CARE ONE

    ANTISEPTIC

    MOUTH

    RINSE

    ORIGINAL FLAVOR

    Kills germs that cause

    Bad Breath, Plaque &

    the gum disease Gingivitis

    ADA

    Accepted mm3.jpg

    American

    Dental

    Association

    1 LITER

    (33.8 FL OZ)

    image description

  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC MOUTH RINSE 
    eucalyptol, menthol, methyl salicylate, thymol mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-318
    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 SALICYLATE0.60 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:41520-318-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/13/1989
    2NDC:41520-318-121500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/13/1989
    3NDC:41520-318-69250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/13/1989
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35603/13/1989
    Labeler - American Sales Company (809183973)
    Registrant - Vi-Jon (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon790752542manufacture(41520-318)
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