Label: ANTISEPTIC- eucalyptol,menthol, methyl salicylate, thymol rinse

  • NDC Code(s): 49348-482-62, 49348-482-89
  • Packager: Strategic Sourcing Services LLC
  • 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 December 16, 2021

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  • Active ingredients

    Eucalyptol 0.092%, Menthol 0.042%  Methyl salicylate 0.060%, Thymol 0.064%

    Purpose

    Antigingivitis, Antiplaque

  • Use

    helps control plaque that leads to gingivitis

  • Warnings

    For this product

    Do not use

    if you have painful or swollen gums, pus from the gum line, loose teeth or increased spacing between the teeth.  See you 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 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 of flossing
  • Other information

    cold weather may cloud this product.  Its antiseptic properties are not affected.  Store at room temperature (57⁰-77⁰F)

  • Inactive ingredients

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

  • ADA Statement

    The ADA council on Scientific affairs Acceptance of Sunmak's Antiseptic Mouth Rinse is based on its finding that the product is effective in helping to prevent and reduce gingivitis and plaque above the gumline when used as directed.

    This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributor of Listerine.

  • Adverse reaction

    Another Quality Product

    Distributed by McKesson

    One Post Street

    San Francisco, CA 94104

    Money Back Quarantee

    Please visit us at

    www.sunmarkbrand.com

    DSP-TN-15000

    DSP-MO-34

    SDS-TN-15012

    664.002/664AS

  • principal display panel

    SUNMARK

    Compare to

    Listerine

    Active Ingredients

    NDC 49348-482-62

    MOUTH

    Rinse

    Antiseptic

    ADA

    Accepted

    Kills germs that cause bad breath, plaque & the gum disease gingivitis

    BLUE MINT

    33.8 FL OZ ( 1 L)

    image description

  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC  
    eucalyptol,menthol, methyl salicylate, thymol rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-482
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    EUCALYPTOL (UNII: RV6J6604TK) (EUCALYPTOL - UNII:RV6J6604TK) EUCALYPTOL.092 kg  in 100 L
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL.042 kg  in 100 L
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE.060 kg  in 100 L
    THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E) THYMOL.064 kg  in 100 L
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    SORBITOL (UNII: 506T60A25R)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49348-482-621 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/15/199008/04/2023
    2NDC:49348-482-891.25 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/15/199008/04/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35608/15/199008/04/2023
    Labeler - Strategic Sourcing Services LLC (116956644)
    Registrant - Vi-Jon (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon790752542manufacture(49348-482)
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