Anti Cavity Rinse

Dosage form: rinse
Ingredients: SODIUM FLUORIDE .05kg in 100L
Labeler: Western Family Foods, Inc
NDC Code: 55312-004

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.

Drug Facts

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

Purpose
Anticavity rinse

Use aids in the prevention of dental cavities

Warning

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

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

The ADA Council on Scientific Affairs' Acceptance of Western Family Anticavity Fluoride Rinse is based on the finding that the product is effective in helping to prevent and reduce tooth decay, when used as directed.

Proudly Distributed by
Western Family Foods, Inc
P.O. Box 4057, Portland, OR 97208 U.S.A.
www. westernfamily.com

This product is not manufactured
or distriubted by Chattem, Inc.,
distributor of Act Bubblegum
Blowout Anticavity Flouride Rinse.

Sealed with printed neckband for your protection.
Western Family
ALCOHOL FREE
ANTICAVITY
FLUORIDE RINSE
KIDS
Bubble Gum
Helps Prevent Cavities
+ Strengthen Teeth
ADA
Accepted
American
Dental Association
COMPARE TO ACT
ANTICAVITY FLUORIDE RINSE
IMPORTANT: READ DIRECTIONS FOR PROPER USE.
18 FL OZ (532 mL)

ANTI CAVITY RINSE
sodium fluoride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55312-004
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (FLUORIDE ION)	SODIUM FLUORIDE	.05 kg in 100 L

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL
CETYLPYRIDINIUM CHLORIDE
POLOXAMER 407
POLYSORBATE 80
PROPYLENE GLYCOL
SODIUM BENZOATE
SODIUM PHOSPHATE
SORBITOL

Packaging
#	Item Code	Package Description
1	NDC:55312-004-44	.5 L in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	05/12/2009

Labeler - Western Family Foods, Inc (192166072)

Registrant - Vi Jon (790752542)

Establishment
Name	Address	ID/FEI	Operations
Vi Jon		790752542	manufacture

Revised: 11/2010

Document Id: 8a60cb2f-5646-4a11-aa2b-1d1ce6dbca63

Set id: 11e75f77-ed41-461b-9244-10ae5266d6db

Version: 1

Effective Time: 20101111

Western Family Foods, Inc

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Anti Cavity Rinse

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