NDC Code(s) : 63029-595-25, 63029-595-12, 63029-595-14
Packager : Medtech Products Inc.

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Compound Wsalicylic acid GEL
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63029-595
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALICYLIC ACID(UNII: O414PZ4LPZ)
(SALICYLIC ACID - UNII:O414PZ4LPZ) 		SALICYLIC ACID170 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
ALCOHOL(UNII: 3K9958V90M)
CAMPHOR (NATURAL)(UNII: N20HL7Q941)
CASTOR OIL(UNII: D5340Y2I9G)
ETHYL ACETATE(UNII: 76845O8NMZ)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(UNII: RFW2ET671P)
HYPOPHOSPHOROUS ACID(UNII: 8B1RL9B4ZJ)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
PYROXYLIN(UNII: KYR8BR2X6O)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63029-595-251 in 1 CARTON 15/03/2014
17 g in 1 TUBE Type 0: Not a Combination Product
2NDC:63029-595-121 in 1 CARTON 15/03/2014
27 g in 1 TUBE Type 1: Convenience Kit of Co-Package
3NDC:63029-595-141 in 1 CARTON 15/03/2014
37 g in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M028 03/15/2014

LABELER - Medtech Products Inc.(122715688)

PRINCIPAL DISPLAY PANEL

Compound W
WART REMOVER SYSTEM
MAXIMUM STRENGTH
FAST ACTING GEL + CONSEAL
Salicylic acid
NET WT 0.25 OZ (7g)

PRINCIPAL DISPLAY PANEL Compound W WART REMOVER SYSTEM MAXIMUM STRENGTH FAST ACTING GEL + CONSEAL Salicylic acid NET WT 0.25 OZ (7g)

PRINCIPAL DISPLAY PANEL

Compound W
Total Care Wart & Skin
Salicylic acid – Wart Remover
GEL NET WT 0.25 OZ (7g)

Compound W Total Care Wart & Skin Salicylic acid – Wart Remover GEL NET WT 0.25 OZ (7g)

PRINCIPAL DISPLAY PANEL

Compound W
Wart Remover
Salicylic acid
MAXIMUM STRENGTH
GEL
NET WT 0.25 OZ (7g)

Compound W Wart Remover Salicylic acid MAXIMUM STRENGTH FAST ACTING GEL NET WT 0.25 OZ (7g)