NDC Code(s) : 65601-704-29, 65601-704-55, 65601-704-04
Packager : Betco Corporation, Ltd.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Antibacterial Foaming Skin CleanserTricolsan SOAP
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65601-704
Route of Administration Topical DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRICLOSAN(UNII: 4NM5039Y5X)
(TRICLOSAN - UNII:4NM5039Y5X) 		TRICLOSAN3.0 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
POTASSIUM COCOATE(UNII: F8U72V8ZXP)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
GLYCERIN(UNII: PDC6A3C0OX)
EDETATE SODIUM(UNII: MP1J8420LU)
FD&C YELLOW NO. 5(UNII: I753WB2F1M)
MAGNESIUM CHLORIDE(UNII: 02F3473H9O)
ALOE VERA Leaf(UNII: ZY81Z83H0X)
METHYLCHLOROISOTHIAZOLINONE(UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE(UNII: 229D0E1QFA)
FD&C RED NO. 40(UNII: WZB9127XOA)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:65601-704-291000 mL in 1 BAG Type 0: Not a Combination Product03/01/2016
2NDC:65601-704-55208000 mL in 1 DRUM Type 0: Not a Combination Product03/01/2016
3NDC:65601-704-043780 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product03/01/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 03/01/2016

PRINCIPAL DISPLAY PANEL

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