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Alcohol-Free Anticavity by ShopKo Stores Operating., LLC

Medically reviewed on Dec 11, 2017

Dosage form: liquid
Ingredients: SODIUM FLUORIDE 0.1mg in 1mL
Labeler: ShopKo Stores Operating., LLC
NDC Code: 37012-482

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 0.02% (0.01% w/v fluoride ion)

Purpose

Anticavity

Use

aids in the prevention of dental cavities

Warnings

Keep out of reach of children.

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 6 years of age and older:

  • use twice daily after brushing your teeth with a toothpaste
  • vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute 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

water, glycerin, cetylpyridinium chloride, flavor, sodium saccharin, phosphoric acid, sodium benzoate, sucralose, poloxamer 407, benzoic acid, disodium phosphate, propylene glycol, red 33, green 3

Sealed with printed neckband for your protection
To Open:
1. Remove Printed Tamper Evident Neckband
2. Squeeze Both tabs at Base of cap While turning the cap until loose.
To Close: Place cap back on bottle and turn cap until it clicks twice and feels secure.

This rinse may cause temporary staing to the surface of teeth. This is not harmful, and adequate brushing may prevent its occurence.

*This product is not manufactured or distributed by Procter & Gamble, distributor of Crest Pro-Health Complete Anticavity 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 1-888-593-0593

Principal display panel

ShopKo

Compare to the active ingredient of Crest*

Alcohol Free

ANTICAVITY FLUORIDE RINSE

Violet Mint

Kills bad breath germs

Helps prevent cavities

Helps strengthen enamel

Cleans teeth

Freshens breath

IMPORTANT: read directions for proper use.

33.8 FL OZ (1 L)

482.001/482AB

ALCOHOL-FREE ANTICAVITY 
sodium fluoride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37012-482
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION0.1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
water 
GLYCERIN 
CETYLPYRIDINIUM CHLORIDE 
SACCHARIN SODIUM 
PHOSPHORIC ACID 
SODIUM BENZOATE 
SUCRALOSE 
POLOXAMER 407 
BENZOIC ACID 
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS 
PROPYLENE GLYCOL 
D&C RED NO. 33 
FD&C GREEN NO. 3 
Packaging
#Item CodePackage Description
1NDC:37012-482-861000 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35507/15/1982
Labeler - ShopKo Stores Operating., LLC (023252638)
Registrant - Vi-Jon (790752542)
Establishment
NameAddressID/FEIOperations
Vi-Jon790752542manufacture(37012-482)

 
ShopKo Stores Operating., 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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