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

  • Label RSS
  • NDC Code(s): 37808-072-12, 37808-072-19, 37808-072-77, 37808-072-86
  • Packager: H-E-B
  • 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 11/13

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

  • 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

    help control plaque that leads to gingivitis

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  • WARNINGS

    Warnings

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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

     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

    • not intended to replace brushing or flossing

    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 unmder 12 years of age - consult a dentist or doctor

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  • Inactive ingredients

    water, alcohol 21.6%, sorbitol, flavor, poloxamer 407, benzoic acid, sodium saccharin, sodium citrate, D+C yellow no. 10,  FD+C green no.3

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  • Disclaimer

    This product is not manufactured or distributed by Johnson + Johnson Healthcare Products, distributor of FreshBurst Listerine Antiseptic Mouthwash.

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  • Adverse Reactions

    MADE WITH PRIDE AND CARE FOR H-E-B

    SAN ANTONIO, TX 78204

    DSP-TN-1500   DSP-MO-34  SDS-TN-15012

    Meets the TSA guidelines for carry-on luggage

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  • Principal display panel

    Compare to Listerine

    H-E-B

    Antiseptic

    Fresh Green

    Mint

    ANTIGINGIVITIS/ANTIPLAQUE

    MOUTH RINSE

    Kills Germs

    Fights Bad Breath

    Fights Plaque

    Fights Gingivitis

    Sealed with printed neckband for your protection

    3.2 FL OZ (94 mL)

    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:37808-072
    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 CITRATE  
    D&C YELLOW NO. 10  
    FD&C GREEN NO. 3  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:37808-072-12 1500 mL in 1 BOTTLE, PLASTIC
    2 NDC:37808-072-86 1000 mL in 1 BOTTLE, PLASTIC
    3 NDC:37808-072-77 500 mL in 1 BOTTLE, PLASTIC
    4 NDC:37808-072-19 94 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 04/25/1995
    Labeler - H-E-B (007924756)
    Registrant - Vi-Jon (790752542)
    Establishment
    Name Address ID/FEI Business Operations
    Vi-Jon 790752542 manufacture(37808-072)
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