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Kids Flouride Rinse by WinCo Foods, LLC

Medically reviewed on January 8, 2018

Dosage form: rinse
Ingredients: SODIUM FLUORIDE 0.2mg in 1mL
Labeler: WinCo Foods, LLC
NDC Code: 67091-104

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 0.05% (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 a toothpaste
  • remove cap
  • pour 10 millilters (10 mL mark on inside of cap); do not fill above 10 mL mark
  • vigourously 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 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, cetylpyridinium chloride, disodium EDTA, disodium phosphate, flavor, poloxamer 407, polysorbate 80, propylene glycol, red 33, sodium benzoate, sodium phosphate, sodium saccharin, sorbitol, water

Questions?

Or to report an adverse event call 800-824-1706

Monday - Friday 9am - 4pm MST

"The ADA Council  on Scientific Affairs' Acceptance of WinCo Food Anticavity Fluoride Rinse is based on its finding that the product is effective in helping to prevent and reduce tooth decay, when used as directed."

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

DISTRIBUTED BY: WINCO FOODS, LLC, BOISE, ID 83704

Principal display panel

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

Compare to the active ingredients in ACT Anticavity Kids Fluoride Rinse*

WinCo Foods

ANTICAVITY Fluoride Rinse

Strong Cavity Protection

Alcohol Free

Helps Strengthen Teeth

ADA Accepted American Dental Association

Bubble Gum Flavor

18 FL OZ (532 mL)

IMPORTANT: READ DIRECTIONS FOR PROPER USE.

004.001/004AE

KIDS FLOURIDE RINSE 
sodium fluoride rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67091-104
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION0.2 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:67091-104-18532 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35502/09/2011
Labeler - WinCo Foods, LLC (056098817)
Registrant - Vi-Jon (150931459)
Establishment
NameAddressID/FEIOperations
Vi-Jon150931459manufacture(67091-104)

 
WinCo Foods, 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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