IODENT ANIMAL KINGDOM BUBBLE GUM- sodium fluoride paste 
United Exchange Corp.

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.

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Active Ingredient                                                                                                           Purpose

Sodium fluoride 0.22%---------------------------------------------------------------------------Anti-Cavity

(Available fluoride content:1000 ppm)

Uses

Aids in the prevention of dental cavities.

Warnings

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Keep out of the reach of children under 6 years of age.

Direction:

Aduts and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.

Children under 6 years: Instruct children under 6 years of age to use a pea size amount. Supervise child's brushing and rinsing (to minimize swallowing).

Children under 2 years of age: Consult a dentist or physician.

Inactive ingredients

water, sorbitol, silica, polyethylene glycol 400, sodium carboxymethylcellulose, sodium lauryl alcohol, gum flavor, titanium dioxide, sodium saccharin, methylparaben, propylparaben, color: pink

Distributed by:

United Exchange Corp.

17211 Valley View Ave.,

Cerritos, CA 90703 USA

image description

IODENT ANIMAL KINGDOM BUBBLE GUM 
sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-106
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.22 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65923-106-851 in 1 CARTON
185 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35506/13/2014
Labeler - United Exchange Corp. (840130579)

Revised: 3/2015
Document Id: 7b2aa0e9-31de-49cb-995e-92f4da438a86
Set id: 7da354c6-aec2-4934-984f-1e70190ccb0e
Version: 2
Effective Time: 20150305
 
United Exchange Corp.