ANTICAVITY FLUORIDE RINSE- sodium fluoride mouthwash

Anticavity Fluoride Rinse by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredients

Sodium fluoride 0.02% (0.01% fluoride ion)

Purpose

Antcavity

Use

aids in the prevention of dental cavities

Warnings 

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 it 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 20⁰ - 25⁰ C (68⁰ - 77⁰ F)
• cold weather may temporarily cloud this product

Inactive ingredients

water, alcohol (21.6 %v/v), sorbitol, poloxamer 407, eucalyptol, flavor, methyl salicylate, menthol, phosphoric acid, sodium saccharin, thymol, disodium phosphate, sucralose, red 40, blue 1

Disclaimer

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

Adverse Reactions

DISTRIBUTED BY

Lidl US, LLC

3500 S. Clark Street

Arlington, VA 22202

QUESTIONS?

1-844-344-5071

www.Lidl.com

163.004/163AE

Principal display panel

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

Kills Bad Breath and Strengthens Teeth to Help Prevent Cavities

Mouthwash

ANTICAVITY

FLUORIDE

• Helps restore enemal
• Helps prevent cavities

COMPARE TO LISTERINE TOTAL CARE FRESH MINT ANTICAVITY MOUTHWASH

SODIUM FLUORIDE AND ACIDULATED

PHOSPHATE TOPICAL SOLUTION

IMPORTANT: read directions for proper use

1.0 L (1 QT 1.8 FL OZ)

INGREDIENTS AND APPEARANCE

ANTICAVITY FLUORIDE RINSE 
sodium fluoride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71141-159
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)
EUCALYPTOL (UNII: RV6J6604TK)
METHYL SALICYLATE (UNII: LAV5U5022Y)
MENTHOL (UNII: L7T10EIP3A)
PHOSPHORIC ACID (UNII: E4GA8884NN)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
THYMOL (UNII: 3J50XA376E)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
SUCRALOSE (UNII: 96K6UQ3ZD4)
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: 71141-159-32	1000 mL in 1 PACKAGE; Type 0: Not a Combination Product	02/09/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	02/09/2017

Labeler - Lidl US, LLC (079389709)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture(71141-159)