ANTIBACTERIAL GOLDEN BURST- triclocarban soap
International Wholesale, Inc.

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

Triclocarban 0.30%

Purpose

Antibacterial

Uses

Helps reduce bacteria on the skin that could cause disease.
Recommended for repeated use

Warnings

For external use only

When using this product:

do not use in or near the eyes. In case of eye contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if:

irritation and redness develops and lasts more than 72 hours.

Keeps 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

Other Information

Store below 110° F (43° C)
May discolor certain fabrics or surfaces

Inactive Ingredients

Sodium Cocoate, Sodium Palmate, Water, Glycerin, Sodium Chloride, Titanium Dioxide, BHT, Fragrance, FD&C Yellow #5

Package Display

label

ANTIBACTERIAL GOLDEN BURST
triclocarban soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52862-120
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)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Product Characteristics
Color	white	Score	no score
Shape	RECTANGLE	Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:52862-120-03	3 in 1 PACKET	08/03/2015
1		90 g in 1 CARTON; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	07/15/2015

Labeler - International Wholesale, Inc. (161872676)