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Anticavity by ShopKo Stores

Dosage form: rinse
Ingredients: SODIUM FLUORIDE 0.05mg in 1mL
Labeler: ShopKo Stores
NDC Code: 37012-213

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

TEP

Sealed with printed neckband for your protection

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, see 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 the 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 minimixe 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, green 3, menthol, methyl salicylate, poloxamer 407, polysorbate 20, potassium sorbate, propylene glycol, sodium benzoate, sodium phosphate, sodium saccharin, sorbitol, water, yellow 5

Disclaimer

This product is not manufactured or distributed by Chattem, Inc, distributor of Act Anticavity Fluoride Rinse`

Adverse reactions

Manufactured by Vi-Jon, Inc.,

One Swan Drive, Smyrna, TN 37167

for Shopko Stores Operating Co., LLC

www.shopko.com

for consumer questions

call 1-888-593-0593

SHOPKO

Satisfaction

Guaranteed by refund or exchange

Principal Display Panel

SHOPKO

COMPARE TO THE ACTIVE INGREDIENT OF ACT

ANTICAVITY

Fluoride

Rinse

Mint Flavor

Strong cavity protection

Helps strengthen teeth

Helps prevent cavities

Freshens breath

Alcohol free

IMPORTANT: read directions for proper use

18 FL OZ (532 mL)

ANTICAVITY 
sodium fluoride rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37012-213
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION0.05 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL 
EDETATE CALCIUM DISODIUM ANHYDROUS 
CETYLPYRIDINIUM CHLORIDE 
EDETATE DISODIUM 
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS 
FD&C GREEN NO. 3 
MENTHOL 
METHYL SALICYLATE 
POLOXAMER 407 
POLYSORBATE 20 
POTASSIUM SORBATE 
PROPYLENE GLYCOL 
SODIUM BENZOATE 
SODIUM PHOSPHATE 
SACCHARIN SODIUM DIHYDRATE 
SORBITOL 
WATER 
FD&C YELLOW NO. 5 
Packaging
#Item CodePackage Description
1NDC:37012-213-44.532 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35506/02/2011
Labeler - ShopKo Stores (023252638)
Registrant - Vi-Jon (790752542)
Establishment
NameAddressID/FEIOperations
Vi-Jon790752542manufacture(37012-213)

 
ShopKo Stores

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Medically reviewed on Jun 18, 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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