Label: ANTISEPTIC BLUE MINT- eucalyptol, menthol, merthyl 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 January 8, 2019

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  • Active ingredients

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

    Purpose

    Antigingivitis/Antiplaque

  • Uses

    Helps reduce plaque that leads to

    • gingivitis
    • bleeding gums
  • Warnings

    Stop use and see your dentist immediately if

    • gingivitis, bleeding, or redness persists for more than 2 weeks
    • you have painful or swollen gums, pus from the gum line, loose teeth, or increasing space between the teeth. These may be signs or symptoms or periodontitis, a serious form of gum disease

    Keep out of reach of children.

    If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center immediately.

  • Directions

    • Adults and children 12 years of age and older: vigorously swish 20 milliliters of rinse between teeth twice a day for 30 seconds then spit out. Do not swallow the rinse.
    • Children 6 to 12 years of age: supervise use
    • Children under 6 years of age: do not use

  • Other information

    • not intended to replace brushing or flossing
    • store at room temperature (59°F - 77°F)
    • cold weather may cloud this product, but will not affect its antiseptic properties
  • Inactive ingredients

    alcohol (21.6%), benzoic acid, flavor, green 3, poloxamer 407, sodium benzoate, sodium saccharin, sorbitol, water.

  • Label Copy

    Image of the label

  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC BLUE MINT 
    eucalyptol, menthol, merthyl salicylate, thymol mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66715-5570
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    EUCALYPTOL (UNII: RV6J6604TK) (EUCALYPTOL - UNII:RV6J6604TK) EUCALYPTOL0.92 mg  in 1 mL
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.42 mg  in 1 mL
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE0.60 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)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66715-5570-8251 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/07/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35601/07/2019
    Labeler - LIL' DRUG STORE PRODUCTS, INC. (093103646)
    Registrant - Apollo Health and Beauty Care Inc. (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apollo Health and Beauty Care Inc.201901209manufacture(66715-5570)
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