Label: FAMILY WELLNESS ORIGINAL AMBER- eucalyptol, menthol, methyl salicylate, thymol mouthwash

  • 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 August 23, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients
    Eucalyptol 0.092%, Menthol 0.042%

    Methyl Salicylate 0.060%, Thymol 0.064%

  • PURPOSE

    Purpose

    Antigingivitis, Antiplaque

    Antigingivitis, Antiplaque

  • INDICATIONS & USAGE

    Usehelps control plaque that leads to gingivitis

  • WARNINGS

    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 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.

  • DOSAGE & ADMINISTRATION

    Directions

    – adults and children 12 years of age and older: vigorously swish 20 mL (2/3 FL OS 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 or flossing

  • STORAGE AND HANDLING

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

  • INACTIVE INGREDIENT

    Inactive ingredients water, alcohol 21.6%, benzoic acid, poloxamer 407, sodium benzoate, caramel.

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY: Midwood Brands, LLC

    500 Volvo Parkway, Chesapeake, VA 23320

    Made in Canada

    * This product is not manufactured or distributed by Johnson & Johnson, distributor of Listerine®.

  • PRINCIPAL DISPLAY PANEL

    COMPARE TO LISTERINE® ORIGINAL*

    FAMILY wellness™

    ORIGINAL AMBER

    MOUTHWASH

    DEEP CLEAN FOR FRESHER BREATH

    Helps Kill Germs that Cause Bad Breath, Plaque and Gingivitis Gum Disease

    33.8 FL OZ (1000 mL)

    a

  • INGREDIENTS AND APPEARANCE
    FAMILY WELLNESS  ORIGINAL AMBER
    eucalyptol, menthol, methyl salicylate, thymol mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-232
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    EUCALYPTOL (UNII: RV6J6604TK) (EUCALYPTOL - UNII:RV6J6604TK) EUCALYPTOL0.092 g  in 100 mL
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.042 g  in 100 mL
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE0.06 g  in 100 mL
    THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E) THYMOL0.064 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    CARAMEL (UNII: T9D99G2B1R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55319-232-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/20/2019
    2NDC:55319-232-23250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/20/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35606/20/2019
    Labeler - Family Dollar Services Inc. (024472631)
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