365 WHOLE FOODS SPEARMINT FLAVORED FLUORIDE MOUTHWASH ANTICAVITY- fluoride mouthwash

Drug Labeling and Warnings

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

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

Purpose

Anticavity

Use

Aids in the prevention of dental cavities

Warnings

keep out of reach of children.

KEEP OUT OF REACH OF CHILDREN

If more than used for rinsing is accidentally swallowed, get medical help or contact a poison Control Center (1-800-22-1222) right away.

Directions

Adults and children 6 years of age and older: Use twice a day after brushing your teeth with a toothpaste.

Vigorously swish 10 milliliters (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out.
Do not swallow the rinse.

Do not eat or drink for 30 minutes after rinsing.

Instruct children under 12 years of age in good rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision.

Children under 6 years of age: consult a dentist or doctor.

Other Information.

This rinse is not intended to replace brushing or flossing

Store at room temperature

Cold weather may temporarily cloud this product

Inactive Ingredients

Water, Alcohol (12%), Sorbitol, Polysorbate 80, Stevia Rebaudiana Leaf Extract, Sodium Benzoate, Natural Flavor, Eucalyptol, Methyl Salicylate, Thymol, Menthol, Citric Acid, Sodium Hydroxide.

Questions, Comments?

1-844-WFM-TALK (1-844-936-8255)

SPL UNCLASSIFIED SECTION

Distributed by: Whole Foods Market | Austin, TX 78703

(c)2024 WHOLE FOODS MARKET IP, INC. | www.wholefoodsmarket.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

365 WHOLE FOODS SPEARMINT FLAVORED FLUORIDE MOUTHWASH ANTICAVITY 
fluoride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42681-0048
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FLUORIDE ION (UNII: Q80VPU408O) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
THYMOL (UNII: 3J50XA376E)
ALCOHOL (UNII: 3K9958V90M)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM BENZOATE (UNII: OJ245FE5EU)
EUCALYPTOL (UNII: RV6J6604TK)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
WATER (UNII: 059QF0KO0R)
MENTHYL SALICYLATE (UNII: 43XOA705ZD)
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)
CITRIC ACID (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42681-0048-1	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M022	03/31/2026

Labeler - WHOLE FOODS (196175616)

Registrant - SOLEVY CO DBA 6 DEGREES COLLECTIVE LLC (056875098)