Label: ANTISPETIC- eucalyptol, menthol, methyl salicylate and thymol mouthwash

  • NDC Code(s): 21130-664-12, 21130-664-77, 21130-664-86
  • Packager: Safeway, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 04/14

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

  • TEP

    Sealed with printed neckband for your protection

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  • Active ingredients

    Active ingredients

    Eucalyptol 0.092%

    Menthol 0.042%

    Methyl salicylate 0.060%

    Thymol 0.064%

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  • Purpose

    Antigingivitis, antiplaque

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  • Use

    helps control plaque that leads to gingivitis

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  • Warnings

    For this product

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  • Do not use

    If you have painful or swollen gums, pus from the gum 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.

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  • Stop use and ask a dentist

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

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  • 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.

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  • Directions

    adults and children 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
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  • Other information

    Cold weather may cloud this product.  Its antiseptic properties are not affected.  Store at room temperature (59⁰-77⁰F)

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  • Inactive ingredients

    water, alcohol 21.6%, sorbitol solution, flavor, poloxamer 407, benzoic acid, sodium saccharin, sodium benzoate, FD&C green no.3

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  • ADA Council Statement

    The ADA Council on Scientific Affairs Acceptance of Safeway Blue Mint Antiseptic Mouthwash is based on its finding that the product is effective in helping to prevent and reduce gingivitis and plque above the gumline, when used as directed

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  • Adverse Reactions

    DISTRIBUTED BY SAFEWAY INC.

    P.O. BOX 99

    PLEASANTON, CA 94566-0009

    1-888-SAFEWAY/www.safeway.com

    PRODUCT OF U.S.A.

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  • Principal display panel

    SAFEWAY

    CARE

    Quality Guaranteed

    ANTISEPTIC

    Mouthwasy

    antigingivitis/antiplaque

    Blue Mint

    Fights plaque & gingivitis

    Kills germs that cause bad breath

    ADA

    Accepted

    American

    Dental

    Association

    500 mL

    (16.9 FL OZ)

    image description

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  • INGREDIENTS AND APPEARANCE
    ANTISPETIC 
    eucalyptol, menthol, methyl salicylate, thymol mouthwash
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:21130-664
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    EUCALYPTOL (EUCALYPTOL) EUCALYPTOL 0.92 mg  in 1 mL
    MENTHOL (MENTHOL) MENTHOL 0.42 mg  in 1 mL
    METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE 0.60 mg  in 1 mL
    THYMOL (THYMOL) THYMOL 0.64 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    ALCOHOL  
    SORBITOL  
    POLOXAMER 407  
    BENZOIC ACID  
    SACCHARIN SODIUM  
    SODIUM BENZOATE  
    FD&C GREEN NO. 3  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:21130-664-86 1000 mL in 1 BOTTLE, PLASTIC
    2 NDC:21130-664-12 1500 mL in 1 BOTTLE, PLASTIC
    3 NDC:21130-664-77 500 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part356 03/15/1998
    Labeler - Safeway, Inc (009137209)
    Registrant - Vi-Jon (790752542)
    Establishment
    Name Address ID/FEI Business Operations
    Vi-Jon 790752542 manufacture(21130-664)
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