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Anticavity by Shopko Stores Operating Co.LLC

Medically reviewed on January 2, 2018

Dosage form: rinse
Ingredients: SODIUM FLUORIDE 10.4mg in 1mL
Labeler: Shopko Stores Operating Co.LLC
NDC Code: 37012-004

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 0.055% (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 toothpaste
  • remove cap
  • pour 10 mililiters (10 mL mark on inside of cap); do not fill above thr 10 mL mark
  • vigorously swish 10 mililiters 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, cetylpridinium chloride, disodium EDTA, disodium phosphate, flavor, poloxamer 407, polysorbate 80, propylene glycol, red 33, sodium benzoate, sodium phosphate, sodium saccharin, sorbitol, water

Sealed with printed neckband for your protection.

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

Manufactured by Vi-Jon, Inc.,

One Swan Dr., Smyrna, TN 37167

for ShopKo Stores Operating Co., LLC

www.shopko.com

For consumer questions call 1-888-593-05936

ShopKo Satisfaction Guaranteed By Refund Or Exchange

Principal Display Panel

ShopKo

Compare to the Active Ingredient of Act*

Kids Anticavity Fluoride Rinse

Bubble Gum Flavor

Strong cavity protection

Helps strengthen teeth mm1.jpg

Helps prevent cavities

Alcohol Free

IMPORTANT: read directions for proper use

18 FL OZ (532 mL)

004.001/004AE

ANTICAVITY 
sodium fluoride rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37012-004
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION10.4 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL 
EDETATE CALCIUM DISODIUM ANHYDROUS 
CETYLPYRIDINIUM CHLORIDE 
EDETATE DISODIUM 
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS 
POLOXAMER 407 
POLYSORBATE 80 
PROPYLENE GLYCOL 
D&C RED NO. 33 
SODIUM BENZOATE 
SODIUM PHOSPHATE 
SACCHARIN SODIUM 
SORBITOL 
WATER 
Packaging
#Item CodePackage Description
1NDC:37012-004-44532 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35506/15/2011
Labeler - Shopko Stores Operating Co.LLC (023252638)
Registrant - Vi-Jon (790752542)
Establishment
NameAddressID/FEIOperations
Vi-Jon790752542manufacture(37012-004)

 
Shopko Stores Operating Co.LLC

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Further information

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

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