Active ingredient

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

Purpose

Anticavity rinse

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, 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 millilters (10 mL mark on inside of cap); do not fill above 10 mL mark
vigourously 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

Other information

store at room temperature

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

Questions?

Call 800-824-1706 Monday - Friday 9am - 4pm MST

DISTRIBUTED BY: WINCO FOODS, LLC, BOISE, ID 83704

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

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Comments & Questions?

800-824-1706

principal display panel

SEALED WITH PRINTED NECKAND FOR YOUR PROTECTION

Compare to the active indredient in ACT Anticavity Kids Flouride Rinse

WinCo FOODS

ANTICAVITY Fluoride Rinse

Strong Cavity Protection

Alcohol Free

Helps Strengthen Teeth

ADA

Accepted

American

Dental

Association

Bubble Gum Flavor

18 FL OZ (532 mL)

IMPORTANT READ DIRECTIONS FOR PROPER USE

image description

KIDS FLOURIDE RINSE
sodium fluoride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:67091-104
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
BENZYL ALCOHOL (UNII: LKG8494WBH)
EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
POLOXAMER 407 (UNII: TUF2IVW3M2)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM PHOSPHATE (UNII: SE337SVY37)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:67091-104-44	532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/09/2011

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M021	02/09/2011

Labeler - WinCo Foods, LLC (056098817)

Registrant - Consumer Product Partners, LLC (119091520)

Name	Address	ID/FEI	Business Operations
Establishment
Consumer Product Partners, LLC		119091514	manufacture(67091-104)

WinCo 004.002/004AE Anticavity Fluoride Rinse, Bubble Gum