NDC Code(s) : 71416-002-00
Packager : Bio Ekuiliber LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ProtocoxilBENZYL ALCOHOL GEL
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71416-002
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZYL ALCOHOL(UNII: LKG8494WBH)
(BENZYL ALCOHOL - UNII:LKG8494WBH) 		BENZYL ALCOHOL100 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)(UNII: 59TL3WG5CO)
WATER(UNII: 059QF0KO0R)
EDETATE DISODIUM ANHYDROUS(UNII: 8NLQ36F6MM)
GLYCERIN(UNII: PDC6A3C0OX)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
MARITIME PINE(UNII: 50JZ5Z98QY)
WHITE PEPPER OIL(UNII: 2AM83DL9FV)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
TROLAMINE(UNII: 9O3K93S3TK)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:71416-002-0047 g in 1 BOTTLE Type 0: Not a Combination Product05/09/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 05/09/2017

PRINCIPAL DISPLAY PANEL

Bottle2