CORALITE ANTIBACTERIAL- 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 0.26% Anti-bacterial

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 Coconut Acid, D&C Green No. 5, D&C Yellow No. 10, FD&C Red No. 4, Fragrance, Glycerin, Hydrogenated Tallow Acid, PEG-12, Pentaerythrityl Tetra-Di-t-Butyl Hydroxyhydrocinnamate, Pentasodium, Pentetate, 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
triclocarban soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:65923-132
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TRICLOCARBAN (UNII: BGG1Y1ED0Y) (TRICLOCARBAN - UNII:BGG1Y1ED0Y)	TRICLOCARBAN	2.6 g in 10 g

Ingredient Name	Strength
Inactive Ingredients
COCONUT ACID (UNII: 40U37V505D)
D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGENATED TALLOW ACID (UNII: Q8Y7S3B85M)
PENTASODIUM PENTETATE (UNII: 961TOZ5L7T)
SODIUM COCOATE (UNII: R1TQH25F4I)
SODIUM PALM KERNELATE (UNII: 6H91L1NXTW)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:65923-132-35	100 g in 1 BOX; Type 0: Not a Combination Product	09/04/2013	06/19/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	09/04/2013	06/19/2017

Labeler - United Exchange Corp (840130579)

Revised: 7/2017

Document Id: 2378ecaa-88bb-46bf-8883-004f2320a84b

Set id: c30a814b-f343-48cb-975b-6bb2e4dcf34b

Version: 2

Effective Time: 20170705

United Exchange Corp

﻿Drug Facts

Drug Facts