ANTICAVITY- sodium fluoride mouthwash

Anticavity by

Drug Labeling and Warnings

Anticavity by is a Otc medication manufactured, distributed, or labeled by Meijer Distribution, Inc, Vi-Jon, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredent

Sodium fluoride 0.0221% (0.01% w/v fluoride ion)

Purpose

Anticavity

Use

aids in the prevention of dental cavities

WARNINGS

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.

Directions

Adults and Children 12 years of age and older:

• use twice daily after brushing your teeth with a toothpaste
• vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute then spit out
• do not swallow the rinse
• do not eat or drink for 30 minutes after rinsing
• supervise children as necessary until capable of using without supervision
• children under 12 years of age: consult a dentist or doctor

Other information

• store at controlled room temperature 20°-25° C to (68° - 77°F)
• cold weather may temporarily cloud this product

Inactive ingredients

water, alcohol (21.6%), sorbitol, poloxamer 407, sodium lauryl sulfate, eucalyptol, flavor, methyl salicylate, thymol, phosphoric acid, sucralose, menthol, disodium posphate, red 40, blue 1

SPL UNCLASSIFIED SECTION

*This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of Listerine Total Care Fresh Anticavity Mouthwash

DISTRIBUTED BY
MEIJER DISTRIBUTION, INC
2929 WALKER AVE NW
GRAND RAPIDS, MI 49544
www. meijer.com

principal display panel

Compare to Listerine Total Care active ingredient

Eucalyptus Mint Anticavity Fluoride Rinse

Sodium Fluoride And Acidulated Phosphate Topical Solution

Multi-Action

6 Benefits:

Help prevent cavities

Restores enamel

Strengthens teeth

Kills bad breath germs

Cleans the entire mouth

Freshens Breath

IMPORTANT: Read directions for proper use.

33.8 FL OZ (1 L)

163.004/163AE

INGREDIENTS AND APPEARANCE

ANTICAVITY 
sodium fluoride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41250-163
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
SORBITOL (UNII: 506T60A25R)
POLOXAMER 407 (UNII: TUF2IVW3M2)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
EUCALYPTOL (UNII: RV6J6604TK)
METHYL SALICYLATE (UNII: LAV5U5022Y)
THYMOL (UNII: 3J50XA376E)
PHOSPHORAMIDIC ACID (UNII: 9Q189608GB)
SUCRALOSE (UNII: 96K6UQ3ZD4)
MENTHOL (UNII: L7T10EIP3A)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41250-163-86	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/18/2009

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	05/18/2009

Labeler - Meijer Distribution, Inc (006959555)

Registrant - Vi Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi Jon		790752542	manufacture(41250-163)