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

365 Whole Foods Market Anticavity/Antigingivitis Mouthwash by

Drug Labeling and Warnings

365 Whole Foods Market Anticavity/Antigingivitis Mouthwash by is a Otc medication manufactured, distributed, or labeled by Whole Foods Market, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42681-0036
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	0.6 mg  in 1 mL
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.1 mg  in 1 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.42 mg  in 1 mL
THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E)	THYMOL	0.64 mg  in 1 mL
EUCALYPTOL (UNII: RV6J6604TK) (EUCALYPTOL - UNII:RV6J6604TK)	EUCALYPTOL	0.92 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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
Shape		Size
Flavor	SPEARMINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42681-0036-1	946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/31/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	01/31/2022

Labeler - Whole Foods Market, Inc. (196175616)