CORALITE ANTIBACTERIAL NATURAL OAT- triclocarban soap 
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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Drug Facts

Active ingredient                                                                          Purpose

Triclocarban 0.13%                                                                   Antibacterial

Uses

for washing to decrease bacteria on the skin

Warnings

For external use only.

When using this product

avoid contact with eyes.

In case of eye contact, flush with water.

Stop use and ask a doctor if

irritation and redness develops.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • wet bar with water
  • lather vigorously and wash skin
  • rinse and dry thoroughly

Inactive ingredients Avena Sativa (Oat) Kernel Flour, Coconut Acid, D&C Green No. 5, D&C Yellow No. 10, Dimethicone, FD&C Red No. 4, Fragrance, Glycerin, Hydrogenated Tallow Avid, PEG-12, Pentaerythrityl Tetra-Di-T-Butyl Hydroxyhydrocinnamate, Pentasodium Pentetate, Petrolatum, Polyquaternium-6, Skin Conditioner, Soap (Sodium Tallowate, Sodium Coconate, and/or Sodium Palm Kernelate), Sodium Chloride, Titanium Dioxide, Triclocarban, Water

Distributed By:

United Exchange Corp

17211 Valley View Ave.

Cerritos, CA 90703 USA

Made in Korea

image description

CORALITE ANTIBACTERIAL NATURAL OAT 
triclocarban soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-133
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRICLOCARBAN (UNII: BGG1Y1ED0Y) (TRICLOCARBAN - UNII:BGG1Y1ED0Y) TRICLOCARBAN1.3 g  in 10 g
Inactive Ingredients
Ingredient NameStrength
OATMEAL (UNII: 8PI54V663Y)  
COCONUT ACID (UNII: 40U37V505D)  
D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROGENATED TALLOW ACID (UNII: Q8Y7S3B85M)  
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
PENTASODIUM PENTETATE (UNII: 961TOZ5L7T)  
PETROLATUM (UNII: 4T6H12BN9U)  
SODIUM COCOATE (UNII: R1TQH25F4I)  
SODIUM PALM KERNELATE (UNII: 6H91L1NXTW)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65923-133-35100 g in 1 BOX; Type 0: Not a Combination Product09/05/201306/19/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/05/201306/19/2017
Labeler - United Exchange Corp (840130579)

Revised: 7/2017
 
United Exchange Corp