Your browser does not support JavaScript! ANTICAVITY (SODIUM FLUORIDE) RINSE [KROGER CO]
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ANTICAVITY (sodium fluoride) rinse
[Kroger Co]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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 Label Sections

Active ingredient

Active ingredient

Sodium fluoride 0.055% (0.02% w/v fluoride ion)

Purpose

Purpose

Anticavity rinse

Use

Use aids in the prevention of dental cavities

Warnings

Warnings

Keep out of reach of children

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

Directions

  • adults and children 6 years of age and older: use once a day after brushing your teeth with toothpaste
  • remove cap
  • pour 10 mililiters (10 mL mark on inside of cap); do not fill above thr 10 mL mark
  • vigorously swish 10 mililiters 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

Other information

  • store at room temperature

Inactive ingredients

Inactive ingredients benzyl alcohol, calcium disodium EDTA, cetylpridinium chloride, disodium EDTA, disodium phosphate, flavor, poloxamer 407, polysorbate 80, propylene glycol, red 33, sodium benzoate, sodium phosphate, sodium saccharin, sorbitol, water

Adverse Reactions

Comments or Questions?

800-632-6900 or www. kroger.com

DISTRIBUTED BY

THE KORGER CO.

CINCINNATI, OH 45202

Principal Display Panel

Sealed with printed neckband for your protection.

IMPORTANT: read directions for proper use

Kroger

Quality Guaranteed

KIDS

Anticavity

Fluoride Rinse

strong cavity protection

alcohol free

helps strengthen teeth

helps prevent cavities

16.0 FL OZ

(500 mL)

bubblegum

Flavor

image description

ANTICAVITY 
sodium fluoride rinse
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:30142-004
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION10.4 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 DescriptionMarketing Start DateMarketing End Date
1NDC:30142-004-77500 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35501/18/2013
Labeler - Kroger Co (006999528)
Registrant - Vi-Jon (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon790752542manufacture(30142-004)

Revised: 1/2013
 
Kroger Co

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