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Anticavity Fluoride Rinse by Army + Air Force Exchange Service

Dosage form: mouthwash
Ingredients: SODIUM FLUORIDE 0.05kg in 100L
Labeler: Army + Air Force Exchange Service
NDC Code: 55301-213

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.

Drug Facts

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 milliliters (10 mL mark on the inside of cap); do not fill above the 10 mL mark
• vigorously swish 10 milliliters 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

Other information • store at room temperature

Inactive ingredients benzyl alcohol, calcium disodium EDTA, cetylpyridinium chloride,  disodium EDTA, disodium phosphate, flavor, green 3, menthol, methyl salicylate, poloxamer 407, polysorbate 20, potassium sorbate, propylene glycol, sodium benzoate, sodium phosphate, sodium saccharin, sorbitol, water, yellow 5

This product 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 Avenue
St. Louis, MO 63114

Ujiquely NY DR since 1960
Anticavity
fluoride rinse
mint
strong cavity protection
alcohol free
IMPORTANT: READ DIRECTIONS
FOR PROPER USE
18 FL OZ (532 mL)

ANTICAVITY FLUORIDE RINSE 
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55301-213
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE0.05 kg  in 100 L
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL 
CETYLPYRIDINIUM CHLORIDE 
MENTHOL 
METHYL SALICYLATE 
POLOXAMER 407 
POLYSORBATE 20 
POTASSIUM SORBATE 
PROPYLENE GLYCOL 
SODIUM BENZOATE 
SODIUM PHOSPHATE 
SORBITOL 
WATER 
Packaging
#Item CodePackage Description
1NDC:55301-213-44.532 L in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35512/24/2004
Labeler - Army + Air Force Exchange Service (001695568)
Registrant - Vi-Jon (150931459)
Establishment
NameAddressID/FEIOperations
Vi-Jon150931459manufacture

Revised: 01/2011
 
Army + Air Force Exchange Service

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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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