Drug Facts

CORALITE ULTRA ANTIBACTERIAL DEODORANT - 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 0.3%....................................................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 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

Distributed By:

United Exchange Corp.

17211 Valley View Ave.

Cerritos, CA 90703 USA

Made in Korea

image description

CORALITE ULTRA ANTIBACTERIAL DEODORANT
triclocarban soap

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

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

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

Labeler - United Exchange Corp (840130579)