Your browser does not support JavaScript! KIDS FLOURIDE RINSE (SODIUM FLUORIDE) RINSE [ARMY + AIR FORCE EXCHANGE SERVICE]
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KIDS FLOURIDE RINSE (sodium fluoride) rinse
[Army + Air Force Exchange Service]


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
Sodium Fluoride 0.05% (0.02% w/v fluoride ion)

Purpose
Anticavity rinse

Use aids in the prevention of dental cavities

Warning

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 milliters (10 mL mark on inside of cap): do not fill above the 10 mL mark
•vigorously 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

This is not manufactured or distributed by Chattem, Inc., distributor of Act

SATISFACTION GUARANTEED OR YOUR MONEY BACK
Manufactured for Your Military Exchanges
By: Vi-Jon
8515 Page Ave
St. Louis, MO 83114

exchange
select
Kids
ANTICAVITY
FLUORIDE RINSE
BUBBLE GUM FLAVOR

Compare to the Active ingredient of Act
Anticavity Fluoride Rinse
Stron cavity protection
Helps strengthen teeth
Helps prevent cavities
Alcohol free
IMPORTANT: read directions for proper use
Sealed with printed neckband for your protection
19 FL OZ (532 mL)
image of principal display panel

KIDS FLOURIDE RINSE 
sodium fluoride rinse
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:55301-004
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE.05 kg  in 100 L
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL 
CETYLPYRIDINIUM CHLORIDE 
POLOXAMER 407 
POLYSORBATE 80 
PROPYLENE GLYCOL 
SODIUM BENZOATE 
SODIUM PHOSPHATE 
SORBITOL 
WATER 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55301-004-44.5 L in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35502/09/2011
Labeler - Army + Air Force Exchange Service (001695568)
Registrant - Vi-Jon (150931459)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon150931459manufacture

Revised: 2/2011
 
Army + Air Force Exchange Service

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