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Anticavity Fluoride Rinse by ShopKo Stores Operating Co., LLC

Medically reviewed on October 4, 2017

Dosage form: mouthwash
Ingredients: SODIUM FLUORIDE 0.1mg in 1mL
Labeler: ShopKo Stores Operating Co., LLC
NDC Code: 37012-163

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 ingredients

Sodium fluoride 0.0221% (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 12 years of age and older:

  • use twice daily after brushing your teeth with toothpaste
  • vigorously swish 10 mL (2 teaspoonfuls) 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
  • supervise children as necessary until capable of using without supervision
  • children under 12 years of age: consult a dentist or doctor

Other information
  • store at controlled room temperature 20⁰ -25⁰ C (68⁰ - 77⁰ F)
  • cold weather may temporarily cloud this product

Inactive ingredients

water, sorbitol solution, alcohol (21.8%), flavors, poloxamer 407, sodium lauryl sulfate, phosphoric acid, sucralose, dibasic sodium phosphate, FD+C yellow no.6, FD+C red no. 40, FD+C blue no. 1

Sealed with printed neckband for your protection

*This product is not manufacturd or distributed by Johnson + Johnson Healthcare Products, distributor of Listerine Total Care Anticavity Mouthwash

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
SHOPKO Satisfaction Guaranteed By Refund Or Exchange

Principal Display Panel

SHOPKO

Anticavity FLUORIDE RISE

Sodium Fluoride and Acidulated Phosphate Topical Solution

Eucalyptus Mint

Helps prevent cavities

Restores enamel

Helps strengthen teeth

Helps kill germs that cause bad breath

IMPORTANT:  Read directions for proper use.

1 Liter (33.8 FL OZ)

163.004/163AE

ANTICAVITY FLUORIDE RINSE 
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37012-163
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 
SORBITOL 
ALCOHOL 
POLOXAMER 407 
SODIUM LAURYL SULFATE 
PHOSPHORIC ACID 
sucralose 
SODIUM PHOSPHATE, DIBASIC 
FD&C YELLOW NO. 6 
FD&C RED NO. 40 
FD&C BLUE NO. 1 
Packaging
#Item CodePackage Description
1NDC:37012-163-861000 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35505/13/2006
Labeler - ShopKo Stores Operating Co., LLC (023252638)
Registrant - Vi Jon (790752542)
Establishment
NameAddressID/FEIOperations
Vi Jon790752542manufacture(37012-163)

 
ShopKo Stores Operating Co., LLC

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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