KIDS FLOURIDE RINSE- 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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Anticavity Fluoride Rinse 004 004.002/004AE

Active ingredient

Sodium Fluoride 0.05% (0.02% w/v fluoride ion)

Purpose

Anticavity rinse

Use

aids in the prevention of dental cavities

Warnings

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 milliters (10 mL mark on 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 minimize swallowing)
• supervise children as necessary until capable of using without supervision
• children under 6 years of age: consult a dentist or doctor

Inactive ingredients

benzyl alcohol, calcium disodium EDTA, cetylpyridinium chloride, disodium EDTA, disodium phosphate, flavor, poloxamer 407, polysorbate 80, propylene glycol, red 33, sodium benzoate, sodium phosphate, sodium saccharin, sorbitol, water

Other information

• store at room temperature

*This is not manufactured or distributed by Chattem, Inc., distributor of Act Anticavity Fuoride Rinse.

Distributed by Hy-Vee, Inc.

West Des Moines, IA 50266

Satisfaction Guaranteed

Call 1-800-289-8343

www.hy-vee.com

principal display panel

Sealed with printed neckband for your protection

Hy-Vee

Strong Cavity protection

Kids

FLUORIDE RINSE ANTI CAVITY FLUORIDE RINSE

BODACIOUS BUBBLE GUM

Compare to the active ingredient of Act*

ALCOHOL FREE

IMPORTANT: Read directions for proper use

18 FL OZ (532 mL)

image description

KIDS FLOURIDE RINSE
sodium fluoride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:42507-004
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	.02 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
BENZYL ALCOHOL (UNII: LKG8494WBH)
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
POLOXAMER 407 (UNII: TUF2IVW3M2)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM PHOSPHATE (UNII: SE337SVY37)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:42507-004-44	532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/11/2003	02/03/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	09/11/2003	02/03/2021

Labeler - Hy-Vee, Inc (006925671)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(42507-004)

Revised: 2/2021

Document Id: a0d35c74-1c5c-4ccc-9bad-ac94382b7f21

Set id: 684e86e0-afac-449b-93f1-39aef564c581

Version: 7

Effective Time: 20210203

Hy-Vee, Inc