ANTICAVITY- sodium fluoride mouthwash

Anticavity by

Drug Labeling and Warnings

Anticavity by is a Otc medication manufactured, distributed, or labeled by DZA Brands, LLC, Vi-Jon, LLC, 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 6 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
• instruct children under 12 yeard of age in good rinsing habits (to minimize swallowing)
• supervise children as necessary until capable of using without up supervision
• children under 6 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 Mint Anticavity Mouthwash

DISTRIBUTED BY: DZA BRANDS, LLC
2110 EXECUTIVE DRIVE
Salisbury, NC 28147
For product questions or concerns, contact us at 1-866-322-2439. Please include UPC number and code from package

principal display panel

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

healthy accents

eucalyptus mint anticavity fluoride mouth rinse

IMPORTANT: Read directions for proper use.

compare to the ingredients of Listerine Total Care Fresh Mint Anticavity Mouthwash*

1 L (33.8 FL OZ)

163.004/163AE

INGREDIENTS AND APPEARANCE

ANTICAVITY 
sodium fluoride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55316-003
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: 55316-003-86	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/13/2006

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	05/13/2006

Labeler - DZA Brands, LLC (090322194)

Registrant - Vi Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi Jon		790752542	manufacture(55316-003)