NDC Code(s) : 52389-161-30
Packager : Alva-Amco Pharmacal Companies, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Fungicure Undecylenic acid LIQUID
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52389-161
Route of Administration Topical DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
UNDECYLENIC ACID(UNII: K3D86KJ24N)
(UNDECYLENIC ACID - UNII:K3D86KJ24N) 		UNDECYLENIC ACID100 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ISOPROPYL ALCOHOL(UNII: ND2M416302)
water(UNII: 059QF0KO0R)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
ACETIC ACID(UNII: Q40Q9N063P)
HYPROMELLOSES(UNII: 3NXW29V3WO)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:52389-161-301 in 1 CARTON
130 mL in 1 BOTTLE, WITH APPLICATOR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333C 01/01/1995

PRINCIPAL DISPLAY PANEL

Fungicure PDP