Anticavity Fluoride Rinse

Anticavity Fluoride Rinse

Drug Labeling and Warnings

Drug Details

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ALCOHOL-FREE ANTICAVITY- sodium fluoride liquid 
ShopKo Stores Operating., LLC

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.

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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)

image description

482.001/482AB

ALCOHOL-FREE ANTICAVITY 
sodium fluoride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 37012-482
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 37012-482-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/15/1982
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/FEIBusiness Operations
Vi-Jon790752542manufacture(37012-482)

Revised: 12/2017
 
ShopKo Stores Operating., LLC


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