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Anti Cavity Rinse

Dosage form: rinse
Ingredients: SODIUM FLUORIDE 0.2mg in 1mL
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.

Anticavity Fluoride Rinse

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

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.

*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

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)

004.001/004AE

ANTI CAVITY RINSE 
sodium fluoride rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55312-004
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION0.2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL 
EDETATE CALCIUM DISODIUM 
CETYLPYRIDINIUM CHLORIDE 
SODIUM ACID PYROPHOSPHATE 
EDETATE DISODIUM 
POLOXAMER 407 
POLYSORBATE 80 
PROPYLENE GLYCOL 
D&C RED NO. 33 
SODIUM BENZOATE 
SODIUM PHOSPHATE 
SACCHARIN SODIUM 
SORBITOL 
WATER 
Packaging
#Item CodePackage Description
1NDC:55312-004-44532 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35505/12/2009
Labeler - Western Family Foods, Inc (192166072)
Registrant - Vi Jon (790752542)
Establishment
NameAddressID/FEIOperations
Vi Jon790752542manufacture(55312-004)

 
Western Family Foods, Inc

Medically reviewed on Oct 8, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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