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Anticavity Fluoride Rinse by DZA Brands, LLC

Dosage form: mouthwash
Ingredients: SODIUM FLUORIDE 0.05kg in 100L
Labeler: DZA Brands, LLC
NDC Code: 55316-213

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 Anticavity Fluoride Rinse

DISTRIBUTED BY: DZA Brands, LLC, 2110 Executive Drive, Salisbury NC 28147
For Product questions or concerns contact us at 1-866-322-2439
Please include UPC code number from package.

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION
IMPORTANT: READ DIRECTIONS FOR PROPER USE
healthy
accents
alcohol-free
anticavity
fluoride rinse
mint flavor

•helps prevent cavities
•helps strengthen teeth
•freshens breath
compare to the active
ingredient of Act
Anticavity Fluoride Rinse
18 FL OZ (532 mL)

ANTICAVITY FLUORIDE RINSE 
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55316-213
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:55316-213-44.532 L in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35501/07/2011
Labeler - DZA Brands, LLC (090322194)
Registrant - Vi-Jon (790752542)
Establishment
NameAddressID/FEIOperations
Vi-Jon790752542manufacture

 
DZA Brands, LLC

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Medically reviewed on Jan 1, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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