Label: 365 WHOLE FOODS MARKET ANTICAVITY/ANTIGINGIVITIS MOUTHWASH- eucalyptol, menthol, methyl salicylate, thymol, sodium fluoride mouthwash

  • NDC Code(s): 42681-0036-1
  • Packager: Whole Foods Market, 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 February 2, 2022

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  • ACTIVE INGREDIENT

    Eucalyptol 0.092%

    Menthol 0.042%

    Methyl Salicylate 0.060%

    Thymol 0.064%

    Sodium Fluoride 0.02% (0.01% w/v fluoride ion)

  • DOSAGE & ADMINISTRATION

    Directions Adults and children 12 years of age and older: Use twice a day after brushing your teeth with a toothpaste • Vigorously swish 10mL of rinse between your teeth for 30 seconds and then spit out. Do not swallow the rinse • Do not eat or drink for 30 minutes after rinsing. • Children under 12 years of age: do not use/consult a doctor.

  • WARNINGS

    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.

    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.

  • 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.

  • INDICATIONS & USAGE

    Uses • Aids in the prevention of dental cavities. • Helps remove plaque that leads to gingivitis, an early form of gum disease. • The combined daily use of a fluoride preventative treatment rinse and a fluoride toothpaste can help reduce the incidence of dental cavities.

  • PURPOSE

    Uses • Aids in the prevention of dental cavities. • Helps remove plaque that leads to gingivitis, an early form of gum disease. • The combined daily use of a fluoride preventative treatment rinse and a fluoride toothpaste can help reduce the incidence of dental cavities.

  • PRINCIPAL DISPLAY PANEL

    PRODUCT LABEL

  • INGREDIENTS AND APPEARANCE
    365 WHOLE FOODS MARKET ANTICAVITY/ANTIGINGIVITIS MOUTHWASH 
    eucalyptol, menthol, methyl salicylate, thymol, sodium fluoride mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42681-0036
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE0.6 mg  in 1 mL
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.1 mg  in 1 mL
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.42 mg  in 1 mL
    THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E) THYMOL0.64 mg  in 1 mL
    EUCALYPTOL (UNII: RV6J6604TK) (EUCALYPTOL - UNII:RV6J6604TK) EUCALYPTOL0.92 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    SPEARMINT OIL (UNII: C3M81465G5)  
    STEVIA LEAF (UNII: 6TC6NN0876)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorSPEARMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42681-0036-1946 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)