365 WHOLE FOODS MARKET ANTIGINGIVITIS MOUTHWASH- eucalyptol, menthol, methyl salicylate, thymol 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 WITHOUT Fluoride

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.

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.

Eucalyptol 0.092%

Menthol 0.042%

Methyl Salicylate 0.060%

Thymol 0.064%

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

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 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.

PRODUCT LABEL

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)

Revised: 12/2022
 
Whole Foods Market, Inc.