IODENT ANIMAL KINGDOM FRUITY- 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.

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

Warnings

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

Directions:

Adults 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 in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision.

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

Inactive ingredients

water, sorbitol, silica, polyethylene, glycol 400, sodium carboxymethylcellulose, sodium lauryl alcohol, fruity 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 FRUITY 
fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-107
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)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65923-107-851 in 1 CARTON
185 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35506/16/2014
Labeler - United Exchange Corp. (840130579)

Revised: 3/2015
Document Id: 4d218f43-6e05-452a-affc-6cfd6747243b
Set id: 53f2d684-64f8-47de-9e24-41539e4a6954
Version: 2
Effective Time: 20150304
 
United Exchange Corp.