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Anticavity Fluoride Rinse by Wakefern Food Corp

Dosage form: rinse
Ingredients: SODIUM FLUORIDE 0.2mg in 1mL
Labeler: Wakefern Food Corp
NDC Code: 41190-104

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 milliliters (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

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

"The ADA Council on Scientific Affairs' Acceptance of ShopRite 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 distributed by Chattem, Inc., distributor of Act Anticavity Fluoride Rinse

We welcome your questions and comments.
Call: 1-800-ShopRite
E-mail: www.shoprite.com
Write: Wakefern Food Corp.
600 York St.
Elizabeth, NJ 07027
Please provide product UPC and codes stamped on product

DISTRIBUTED BY
WAKEFERN FOOD CORPORATION,
5000 RIVERSIDE DRIVE
KEASBEY,NJ 08832

Compare to the active ingredient of ACT*
ANTICAVITY FLUORIDE RINSE
For Kids
Strong Cavity Protection
Alcohol Free
BUBBLE GUM BLAST
ADA Accepted American Dental Association
IMPORTANT: Read directions for proper use.
18 FL OZ (532 mL)

004.001/004AE

ANTICAVITY FLUORIDE RINSE 
sodium fluoride rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41190-104
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 
EDETATE DISODIUM 
POLOXAMER 407 
POLYSORBATE 80 
PROPYLENE GLYCOL 
D&C RED NO. 33 
SODIUM BENZOATE 
SODIUM PHOSPHATE 
SACCHARIN SODIUM 
SORBITOL 
WATER 
Product Characteristics
Color    Score    
ShapeSize
FlavorBUBBLE GUM (Bubble Gum Blast) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:41190-104-44500 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35510/19/2007
Labeler - Wakefern Food Corp (069722418)
Registrant - Vi Jon (790752542)
Establishment
NameAddressID/FEIOperations
Vi Jon790752542manufacture(41190-104)

 
Wakefern Food Corp

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Medically reviewed on Jan 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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