NDC Code(s) : 52389-638-01, 52389-638-07
Packager : Alva-Amco Pharmacal Companies, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

LysimaxBenzalkonium chloride, menthol, petrolatum OINTMENT
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52389-638
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Benzalkonium Chloride(UNII: F5UM2KM3W7)
(Benzalkonium - UNII:7N6JUD5X6Y) 		Benzalkonium Chloride1.3 mg in 1 g
Menthol(UNII: L7T10EIP3A)
(Menthol - UNII:L7T10EIP3A) 		Menthol10 mg in 1 g
Petrolatum(UNII: 4T6H12BN9U)
(Petrolatum - UNII:4T6H12BN9U) 		Petrolatum970 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
Lysine hydrochloride(UNII: JNJ23Q2COM)
Water(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:52389-638-071 in 1 CARTON
1NDC:52389-638-017 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 09/04/2013

PRINCIPAL DISPLAY PANEL

Lysimax PDP