CORALITE ULTRA ANTIBACTERIAL DEODORANT- triclocarban soap

Coralite Ultra Antibacterial Deodorant by

Drug Labeling and Warnings

Coralite Ultra Antibacterial Deodorant by is a Otc medication manufactured, distributed, or labeled by United Exchange Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient                                                            Purpose

Triclocarban 0.3%....................................................Antibacterial

PURPOSE

Uses

• for washing to decrease bacteria on the skin
  

WARNINGS

Warnings For external use only.

WHEN USING

When using this product avoid contact with eyes. In case of eye contact, flush with water.

STOP USE

Stop use and ask a doctor if irritation and redness develops.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

Directions

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

INACTIVE INGREDIENT

Inactive ingredients soap (sodium tallowate, sodium cocoate, sodium palmate types), water, glycerin, fragrance, sodium chlroide, palm acid or tallowate acid, PEG-6 methyl ether, sorbitol, tetrasdoium etidronate, BHT, pentasodium pentetate, FD&C yellow no. 5, D&C yellow no. 8, FD&C red no. 4

DOSAGE & ADMINISTRATION

Distributed By:

United Exchange Corp.

17211 Valley View Ave.

Cerritos, CA 90703 USA

Made in Korea

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CORALITE ULTRA ANTIBACTERIAL DEODORANT  
triclocarban soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65923-807
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRICLOCARBAN (UNII: BGG1Y1ED0Y) (TRICLOCARBAN - UNII:BGG1Y1ED0Y)	TRICLOCARBAN	0.3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SODIUM COCOATE (UNII: R1TQH25F4I)
SODIUM PALMATE (UNII: S0A6004K3Z)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PALM ACID (UNII: B6G0Y5Z616)
PEG-6 METHYL ETHER (UNII: WXH089JZ5E)
SORBITOL (UNII: 506T60A25R)
PENTASODIUM PENTETATE (UNII: 961TOZ5L7T)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C YELLOW NO. 8 (UNII: 93X55PE38X)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65923-807-35	100 g in 1 PACKAGE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/30/2014

Labeler - United Exchange Corp (840130579)