ANTICAVITY FLUORIDE RINSE - sodium fluoride mouthwash 
Geiss, Destin + Dunn, Inc

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 ingredients
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

Sealed With Printed Neckband For Your Protectin
GoodSense
Anticavity
Fluoride
Rinse

Strong Cavity Protection
Alcohol Free
Mint
ADA
Accepted
American
Dental
Associatin
IMPORTANT:
Read Directions For Proper Use
Compare to active ingredients of
ACT Anticavity Fluoride Rinse
100%
Satisfaction
Guaranteed
18 FL OZ (532 mL)
image of principal display panel
ANTICAVITY FLUORIDE RINSE 
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75981-213
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE.05 kg  in 100 L
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL (UNII: LKG8494WBH)  
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
MENTHOL (UNII: L7T10EIP3A)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM PHOSPHATE (UNII: SE337SVY37)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75981-213-44.532 L in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35508/17/2007
Labeler - Geiss, Destin + Dunn, Inc (076059836)
Registrant - Vi-Jon (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon790752542manufacture

Revised: 4/2011
Document Id: 35497993-615b-4e57-87a8-da03214720ec
Set id: 10cbc8d2-5a7e-42ae-8404-00afd565b709
Version: 1
Effective Time: 20110422
 
Geiss, Destin + Dunn, Inc