Label: POLY INTERFERENT MOUTHWAS- eucalyptol, menthol, methyl salicylate, thymol mouthwash

  • Category: HUMAN OTC DRUG LABEL

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 October 31, 2021

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  • Active Ingredients

    Eucalyptol 0.092%
    Menthol 0.042%
    Methyl Salicylate 0.060%
    Thymol 0.064%

  • Purposes

    Antiplaque/Antigingivitis

  • Uses

    Helps Prevent and Reduce

    • Plaque
    • Gingivitis
  • Warnings

    Do not use in children under 12 years of age.

    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.

  • Keep Out of Reach of Children

    Keep Out of Reach of Children

  • Directions

    Rinse full strength for 30 seconds with 20 mL (2/3 fluid ounce or 4 teaspoonsfuls) morning and night.

    Do not swallow

  • Inactive Ingredients

    Alcohol (26.9%), Benzoic Acid, Citric Acid Anhydrous, Iota-Carrageenan, Peppermint Oil, Sodium Benzoate, Sorbitol, Water and Xylitol Crystalline

  • Other Information

    • Store at room temperature
    • Cold weather may cloud this product, its antiseptic properties are not affected.
    • Do not Use If Seal Cap Is Broken or Missing
  • Questions/Drug Facts-Back Label

    Drug Facts

  • Principal Display Panel

    Poly Interferent

  • INGREDIENTS AND APPEARANCE
    POLY INTERFERENT MOUTHWAS 
    eucalyptol, menthol, methyl salicylate, thymol mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82005-322
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    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
    EUCALYPTOL (UNII: RV6J6604TK) (EUCALYPTOL - UNII:RV6J6604TK) EUCALYPTOL0.92 mg  in 1 mL
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM0.42 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    .IOTA.-CARRAGEENAN (UNII: 3582R1F52W)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    WATER (UNII: 059QF0KO0R)  
    XYLITOL (UNII: VCQ006KQ1E)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SORBITOL (UNII: 506T60A25R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82005-322-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product11/05/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35611/05/2021
    Labeler - KOunter Dfense BioSciences, Inc. (118118898)
    Registrant - KOunter Dfense BioSciences, Inc. (118118898)
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