Label: 365 WHOLE FOODS MARKET ANTIGINGIVITIS MOUTHWASH- 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 December 7, 2022

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  • DOSAGE & ADMINISTRATION

    Adults and children 12 years of age and older: Vigorously swish 20mL of rinse between your teeth twice a day for 30 seconds and then spit out. • Do not swallow the rinse • Children under 12 years of age: do not use/consult a doctor.

  • WARNINGS

    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 right away.

    • Stop use and ask a dentist if • Gingivitis, bleeding, or redness persists for more than 2 weeks. • You have painful of swollen gums, pus from the gum line, loose teeth, or increasing spacing between teeth. These may be signs or symptoms of periodontitis, a serious from of gum disease.

    If pregnant or breast-feeding, ask a health professional before use.

  • ACTIVE INGREDIENT

    Eucalyptol 0.092%

    Menthol 0.042%

    Methyl Salicylate 0.060%

    Thymol 0.064%

  • PURPOSE

    Helps remove plaque that leads to gingivitis, an early form of gum disease.

  • INDICATIONS & USAGE

    Adults and children 12 years of age and older: Vigorously swish 20mL of rinse between your teeth twice a day for 30 seconds and then spit out. • Do not swallow the rinse • Children under 12 years of age: do not use/consult a doctor.

  • INACTIVE INGREDIENT

    Inactive ingredients water, ethyl alcohol (21.6% v/v), sorbitol, flavor, cocamidopropyl betaine, citric acid, stevia rebaudiana leaf extract, sodium citrate, sodium benzoate, mentha piperita (peppermint) oil, mentha spicata (spearmint) oil.

  • PRINCIPAL DISPLAY PANEL

    PRODUCT LABEL

  • INGREDIENTS AND APPEARANCE
    365 WHOLE FOODS MARKET ANTIGINGIVITIS MOUTHWASH 
    eucalyptol, menthol, methyl salicylate, thymol mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42681-0037
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    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 (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.42 mg  in 1 mL
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE0.6 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SPEARMINT OIL (UNII: C3M81465G5)  
    SORBITOL (UNII: 506T60A25R)  
    ALCOHOL (UNII: 3K9958V90M)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorSPEARMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42681-0037-1946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/31/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35601/31/2022
    Labeler - Whole Foods Market, Inc. (196175616)
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