ANTICAVITY- sodium fluoride rinse

Anticavity by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredient

Sodium fluoride 0.02% (0.01% w/v fluoride ion)

Purpose

Anticavity rinse

Use

aids in the prevention of dental cavities

Warning

for this product

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 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

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

Inactive ingredients

water, sorbitol, propylene glycol, poloxamer 407, sodium lauryl sulfate, flavor, sodium benzoate, phosphoric acid, eucalyptol, methyl salicylate, thymol, sodium saccharin, menthol, disodium phosphate, sucralose, Mentha viridis (spearmint) leaf oil, Mentha piperita (peppermint) oil, red 40, blue 1

Disclaimers

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

**This product is not intended to replace brushing or flossing.

Adverse reactions section

DISTRIBUTED BY PUBLIX SUPER MARKETS, INC.

3300 PUBLIX CORPORATE PARKWAY

LAKELAND, FL 33811 publix.com

PUBLIX GUARNTEE: COMPLETE SATIFACTION OR YOUR MONEY BACK

SEALED WITH PRINTD NECKBND FOR YOUR PROTECTION

Publix

principal display panel

P

ANTICAVITY

alcoholfree

MOUTHWASH

Sodium Fluoride & Acidulated Phosphate Topical Solution

Fress mint flavor

• Restores enamel
• Helps strengthen teeth to fight cavities
• Kills bad breath germs
• Cleans the entire mouth**
• Freshens breath

*Compare to Listerine ®Total Care Zero Alcohol Anticavity Mouthwash

IMPORTANT: Read directions for proper use.

33.8 FL OZ (1.05 QT) 1 L

INGREDIENTS AND APPEARANCE

ANTICAVITY 
sodium fluoride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 56062-971
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.02 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLOXAMER 407 (UNII: TUF2IVW3M2)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM BENZOATE (UNII: OJ245FE5EU)
PHOSPHORIC ACID (UNII: E4GA8884NN)
EUCALYPTOL (UNII: RV6J6604TK)
METHYL SALICYLATE (UNII: LAV5U5022Y)
THYMOL (UNII: 3J50XA376E)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SPEARMINT OIL (UNII: C3M81465G5)
PEPPERMINT OIL (UNII: AV092KU4JH)
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: 56062-971-86	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/08/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	10/08/2019

Labeler - publix (006922009)

Registrant - Consumer Product Partners, LLC (119091520)

Establishment
Name	Address	ID/FEI	Business Operations
Consumer Product Partners, LLC		119091514	manufacture(56062-971)