NDC Code(s) : 58980-631-90, 58980-630-14
Packager : Stratus Pharamceuticals, Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

SalacynSalicylic Acid CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58980-631
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 Acid24 g in 400 g
Inactive Ingredients
Ingredient Name Strength
Ammonium Lactate(UNII: 67M901L9NQ)
Cetostearyl Alcohol(UNII: 2DMT128M1S)
Polysorbate 60(UNII: CAL22UVI4M)
Glycerin(UNII: PDC6A3C0OX)
Cetyl Alcohol(UNII: 936JST6JCN)
Mineral Oil(UNII: T5L8T28FGP)
Dimethicone 350(UNII: 2Y53S6ATLU)
Water(UNII: 059QF0KO0R)
Edetate Disodium(UNII: 7FLD91C86K)
Glyceryl Monostearate(UNII: 230OU9XXE4)
Methylparaben(UNII: A2I8C7HI9T)
Polyoxyl 100 Stearate(UNII: YD01N1999R)
Phenoxyethanol(UNII: HIE492ZZ3T)
Propylparaben(UNII: Z8IX2SC1OH)
Trolamine(UNII: 9O3K93S3TK)
Product Characteristics
Color WHITE Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:58980-631-90400 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 03/23/2009
SalacynSalicylic Acid LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58980-630
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 Acid24.84 mg in 414 mL
Inactive Ingredients
Ingredient Name Strength
Ammonium Lactate(UNII: 67M901L9NQ)
Cetostearyl Alcohol(UNII: 2DMT128M1S)
Polysorbate 60(UNII: CAL22UVI4M)
Glycerin(UNII: PDC6A3C0OX)
Cetyl Alcohol(UNII: 936JST6JCN)
Mineral Oil(UNII: T5L8T28FGP)
Dimethicone 350(UNII: 2Y53S6ATLU)
Water(UNII: 059QF0KO0R)
Edetate Disodium(UNII: 7FLD91C86K)
Glyceryl Monostearate(UNII: 230OU9XXE4)
Methylparaben(UNII: A2I8C7HI9T)
Polyoxyl 100 Stearate(UNII: YD01N1999R)
Propylparaben(UNII: Z8IX2SC1OH)
Trolamine(UNII: 9O3K93S3TK)
Product Characteristics
Color WHITE Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:58980-630-14414 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 03/23/2009

PRINCIPAL DISPLAY PANEL

NDC 58980-631-90

Rx only

SALACYN
CREAM

(6% Salicylic Acid)

STRATUS
PHARMACEUTICALS INC

Net WT. 400 grams

PRINCIPAL DISPLAY PANEL - 400 g Bottle Label

PRINCIPAL DISPLAY PANEL

NDC 58980-630-14

Rx only

SALACYN
LOTION

(6% Salicylic Acid)

STRATUS
PHARMACEUTICALS INC

Net WT. 14.0 fl. oz. (414 mL)

PRINCIPAL DISPLAY PANEL - 414 mL Bottle Label