Label: ANTISEPTIC LIL DRUG STORE PRODUCTS- eucalyptol, menthol, unspecified form, methyl salicylate, and thymol liquid

  • NDC Code(s): 66715-6861-4
  • Packager: Lil' Drug Store Products, Inc
  • 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 October 13, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Eucalyptol 0.092%, Menthol 0.042%Antigingivitis, Antiplaque
    Methyl salicylate 0.060%, Thymol 0.064%Antigingivitis, Antiplaque
  • Use

    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 of periodontitis, a serious form of gum disease.

    Keep out of reach of children under 6 years of age.

    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 oldervigorously 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 agesupervise use
    children under 6 years of agedo not use
  • Other information

    • not intended to replace brushing or flossing
    • store at room temperature (59°-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, polaxamer 407, sodium benzoate, sodium saccharin, sorbitol, water

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Lil' Drug Store Products, Inc.
    9300 Earhart Lane SW
    Cedar Rapids, IA 52404

  • PRINCIPAL DISPLAY PANEL - 251 mL Bottle Label

    QUALITY
    ⋆ GUARANTEED ⋆

    Compare to the Active Ingredients
    in Listerine ® Cool Mint ®*

    Blue Mint

    Antiseptic
    Mouthwash
    Antigingivitis/Antiplaque

    Helps remove germs that cause
    • Bad Breath • Plaque • Gingivitis

    8.5 FL OZ (251 mL)

    Lil'
    Drug Store ®

    PRINCIPAL DISPLAY PANEL - 251 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC   LIL DRUG STORE PRODUCTS
    eucalyptol, menthol, unspecified form, methyl salicylate, and thymol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66715-6861
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    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
    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
    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)  
    Product Characteristics
    ColorblueScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66715-6861-4250 mL in 1 BOTTLE; Type 0: Not a Combination Product07/29/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35612/01/2014
    Labeler - Lil' Drug Store Products, Inc (093103646)
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