ANTI CAVITY RINSE- sodium fluoride rinse
Western Family Foods, 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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Western Family 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

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 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

adverse reaction

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.

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

Proudly Distributed by

Western Family Foods, Inc

P.O. Box 4057, Portland, OR 97208 U.S.A.

www. westernfamily.com

004.002/004AE

principal display panel

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

COPARE TO ACT ANTICAVITY FLUORIDE RINSE

IMPORTANT: READ DIRECTIOS FOR PROPER USE

18 FL OZ (532 mL)

image description

ANTI CAVITY RINSE
sodium fluoride rinse

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.2 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
BENZYL ALCOHOL (UNII: LKG8494WBH)
EDETATE CALCIUM DISODIUM (UNII: 25IH6R4SGF)
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM ACID PYROPHOSPHATE (UNII: H5WVD9LZUD)
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:55312-004-44	532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/12/2009	09/18/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	05/12/2009	09/18/2020

Labeler - Western Family Foods, Inc (192166072)

Registrant - Vi Jon (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi Jon		790752542	manufacture(55312-004)

Revised: 9/2020

Document Id: f07cd3f7-137e-49ad-9746-cd22f421242a

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

Version: 7

Effective Time: 20200918

Western Family Foods, Inc