NDC Code(s) : 43269-680-17
Packager : SJ Creations, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Citrus Burst Antibacterial Hand Wash Triclosan LIQUID
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43269-680
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRICLOSAN(UNII: 4NM5039Y5X)
(TRICLOSAN - UNII:4NM5039Y5X) 		TRICLOSAN.2 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
COCAMIDOPROPYL BETAINE(UNII: 5OCF3O11KX)
COCO DIETHANOLAMIDE(UNII: 92005F972D)
GLYCERIN(UNII: PDC6A3C0OX)
POLYSORBATE 20(UNII: 7T1F30V5YH)
EDETATE DISODIUM(UNII: 7FLD91C86K)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
METHYLISOTHIAZOLINONE(UNII: 229D0E1QFA)
OXYBENZONE(UNII: 95OOS7VE0Y)
METHYLCHLOROISOTHIAZOLINONE(UNII: DEL7T5QRPN)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
AMMONIUM LAURYL SULFATE(UNII: Q7AO2R1M0B)
POLYOXYL 50 HYDROGENATED CASTOR OIL(UNII: R07D3A9614)
FD&C YELLOW NO. 5(UNII: I753WB2F1M)
FD&C RED NO. 40(UNII: WZB9127XOA)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43269-680-17517 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 03/31/2011

PRINCIPAL DISPLAY PANEL





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