Label: ANTISEPTIC BLUE MINT MOUTHWASH- methyl salicylate, menthol, unspecified form, eucalyptol, and thymol liquid

  • 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 February 3, 2020

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  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Eucalyptol 0.092% , Menthol 0.04%Antigingivitis , Antiplaque
    Methyl Salicylate0.060%,Thymol,0.064%Antigingivitis , Antiplaque
  • Use

    Helps control plaque that leads to gingivitis

  • WARNINGS

    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 a sign of periodontitis, as 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….vigously swish 20 ml between teeth for 30 seconds then spit out; do not swallow.

    Children under 12 years of age…. Consult a dentist or doctor

    *Rinse is not intended to replace brushing or flossing

  • Other Information

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

  • Inactive Ingredients

    Water, Alcohol 21.6%, Polysorbate 80,Sorbitol,Flavor, Benzoic Acid, Sodium Saccharin, Sodium Benzoate, Blue 1, Yellow 5

  • PRINCIPAL DISPLAY PANEL

    antiseptic-01

  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC BLUE MINT MOUTHWASH 
    methyl salicylate, menthol, unspecified form, eucalyptol, and thymol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71627-128
    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
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM0.42 mg  in 1 mL
    Eucalyptol (UNII: RV6J6604TK) (Eucalyptol - UNII:RV6J6604TK) Eucalyptol0.92 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) 216 mg  in 1 mL
    SORBITOL (UNII: 506T60A25R)  
    Benzoic Acid (UNII: 8SKN0B0MIM)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Polysorbate 80 (UNII: 6OZP39ZG8H)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Product Characteristics
    ColorBLUEScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71627-128-013785 mL in 1 JUG; Type 0: Not a Combination Product06/05/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35606/05/2017
    Labeler - Fore Supply, Inc (025126459)
    Registrant - Fore Supply, Inc (025126459)
    Establishment
    NameAddressID/FEIBusiness Operations
    HealthSpecialty794053863MANUFACTURE(71627-128)
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