365 WHOLE FOODS MARKET ANTICAVITY/ANTIGINGIVITIS MOUTHWASH- eucalyptol, menthol, methyl salicylate, thymol, sodium fluoride mouthwash 
Whole Foods Market, Inc.

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.

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WFM PLD Listing Mouthwash with Fluoride

Eucalyptol 0.092%

Menthol 0.042%

Methyl Salicylate 0.060%

Thymol 0.064%

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

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.

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 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.

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.

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.

PRODUCT LABEL

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)

Revised: 5/2022
Document Id: ded13147-455d-52f1-e053-2a95a90afb29
Set id: d659c511-5a55-694c-e053-2a95a90a684f
Version: 4
Effective Time: 20220512
 
Whole Foods Market, Inc.