ANTICAVITY- sodium fluoride rinse
Walgreen Co.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Walgreens 213.002 213AE rev 2

TEP

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

Active Ingredients

Sodium fluoride 0.05% (0.02% 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, seek professional assistance or contact a Poison Control Center immediately

Directions

adults and children 6 years of age and older: use once a day after brushing your teeth with a toothpaste
remove cap
pour 10 milliliters (10 mL mark on the inside of cap); do not fill above the 10 mL mark
vigorously swish 10 milliliters 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 minimixe 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 room temperature

Inactive ingredients

water, sorbitol, menthol, methyl salicylate, flavor, cetylpyridinium chloride, sodium saccharin, poloxamer 407, polysorbate 20, propylene glycol, sodium phosphate, disodium phosphate, calcium disodium EDTA, disodium EDTA, sodium benzoate, potassium sorbate, benzyl alcohol, green 3, yellow 5

Disclaimer

This product is not manufactured or distributed by Chattem, Inc, distributor of Act Anticavity Fluoride Rinse

ADA Council Statement

The ADA Coucil on Scientific Affairs Acceptance of Walgreens Mint Anticavity Fluoride Rinse is based on its finding that the product is effective in helping to prevent and reduce tooth decay, when used as directed.

Questions or comments?

1-800-925-4733

Adverse reactions section

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD,IL 60015

100% SATISFACTION GUARANTEED

walgrens.com 2013 Walgreen Co.

MADE IN U.S.A. WITH U.S. AND FOREIGN COMPONENTS

213.002/213AE rev 2

principal display panel

Well at

Walgreens

ANTICAVITY

Fluoride

Rinse

Helps prevent cavities & strengthnes teeth
Alcohol free
Freshens breath
IMPORTANT: Read directions for proper use

ADA

Accepted

American

Dental

Asociation

MINT

Compare to ACT active ingredient

18 FL OZ (532 mL)

image description

ANTICAVITY
sodium fluoride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0363-0070
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.05 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
water (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
MENTHOL (UNII: L7T10EIP3A)
METHYL SALICYLATE (UNII: LAV5U5022Y)
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
poloxamer 407 (UNII: TUF2IVW3M2)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM PHOSPHATE (UNII: SE337SVY37)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
EDETATE CALCIUM DISODIUM (UNII: 25IH6R4SGF)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
BENZYL ALCOHOL (UNII: LKG8494WBH)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0363-0070-44	532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/23/2013	06/09/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	09/23/2013	06/09/2020

Labeler - Walgreen Co. (008965063)

Registrant - Vi-Jon (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon		790752542	manufacture(0363-0070)

Revised: 6/2020

Document Id: 11ad74b4-e0dc-42ef-bd75-c563abb46c1a

Set id: bde05cf0-dc83-4ec7-b989-5c37ed10ec6e

Version: 5

Effective Time: 20200609

Walgreen Co.