ANTICAVITY- sodium fluoride rinse
Hy-Vee, Inc.

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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Hy Vee 213.002 213AE rev 2

TEP

Sealed with printed neckband for your protection

Active ingredient

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 for brushing your teeth with a toothpaste
remove cap
pour 10 milliliters (10 mL mark on inside of cap) do not fill above 10 mL mark
vigorously swish 10 milliliter 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 informaton

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

Adverse reaction

DISTRIBUTED BY HY-VEE, INC

5820 WESTOWN PARKWAY

WEST DES MOINES, IA 50266

SATISACTION GUARANTEED OR

PURCHASE PRICE REFUNDED

FOR INFORMATION CALL

1-800-289-8343

www.hy-vee.com

213.002/213AE rev 2

principal display panel

HyVee

Compare to the active ingredients of Act

Anticavity

Fluoride Rinse

Mint

Alcohol free
Strong cavity protection
Helps strengthen teeth
Freshens Breath

IMPORTANT: read directions for proper use

18 FL OZ (532 mL)

image description

ANTICAVITY
sodium fluoride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:42507-213
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Sodium fluoride (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.2 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, MONOHYDRATE (UNII: BWZ7K44R51)
EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)
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:42507-213-44	532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/06/2003	05/14/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	08/06/2003	05/14/2020

Labeler - Hy-Vee, Inc. (006925671)

Registrant - Vi-Jon Inc (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, Inc		790752542	manufacture(42507-213)

Revised: 5/2020

Document Id: 7a2846c2-5cd5-4d7d-9855-33358b8694d1

Set id: 13a05bff-ddf8-42ef-a841-a3fc4d43a182

Version: 9

Effective Time: 20200515

Hy-Vee, Inc.