NDC Code(s) : 45802-818-41, 45802-806-01
Packager : Perrigo New York Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

salicylic acidSalicylic Acid LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:45802-818
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 ACID6 mg in 100 mL
Inactive Ingredients
Ingredient Name Strength
AMMONIUM LACTATE(UNII: 67M901L9NQ)
BEHENTRIMONIUM CHLORIDE(UNII: X7GNG3S47T)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
CETYL ALCOHOL(UNII: 936JST6JCN)
DIMETHICONE 350(UNII: 2Y53S6ATLU)
EDETATE DISODIUM(UNII: 7FLD91C86K)
GLYCERIN(UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
METHYLPARABEN(UNII: A2I8C7HI9T)
MINERAL OIL(UNII: T5L8T28FGP)
PEG-100 STEARATE(UNII: YD01N1999R)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
WATER(UNII: 059QF0KO0R)
STEARYL ALCOHOL(UNII: 2KR89I4H1Y)
TROLAMINE(UNII: 9O3K93S3TK)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:45802-818-41414 mL in 1 BOTTLE Type 0: Not a Combination Product27/09/2007
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 09/27/2007 01/01/2019
salicylic acidSalicylic Acid CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:45802-806
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 ACID6 g in 100 g
Inactive Ingredients
Ingredient Name Strength
AMMONIUM LACTATE(UNII: 67M901L9NQ)
BEHENTRIMONIUM CHLORIDE(UNII: X7GNG3S47T)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
CETYL ALCOHOL(UNII: 936JST6JCN)
DIMETHICONE 350(UNII: 2Y53S6ATLU)
EDETATE DISODIUM(UNII: 7FLD91C86K)
GLYCERIN(UNII: PDC6A3C0OX)
GLYCERYL STEARATE SE(UNII: FCZ5MH785I)
METHYLPARABEN(UNII: A2I8C7HI9T)
MINERAL OIL(UNII: T5L8T28FGP)
PEG-100 STEARATE(UNII: YD01N1999R)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
WATER(UNII: 059QF0KO0R)
STEARYL ALCOHOL(UNII: 2KR89I4H1Y)
TROLAMINE(UNII: 9O3K93S3TK)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:45802-806-01400 g in 1 BOTTLE Type 0: Not a Combination Product09/07/2007
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 09/07/2007 06/01/2018

PRINCIPAL DISPLAY PANEL

Salicylic Acid Lotion, 6%

Rx Only

Salicylic Acid Lotion, 6% Front LabelSalicylic Acid Lotion, 6% Front Label Salicylic Acid Lotion, 6% Front LabelSalicylic Acid Lotion, 6% Front Label

Salicylic Acid Lotion, 6% Back Label

PRINCIPAL DISPLAY PANEL

Salicylic Acid Cream, 6%

Rx Only

Salicylic Acid Cream, 6% Front Label ImageSalicylic Acid Cream, 6% Front Label Image Salicylic Acid Cream, 6% Front Label ImageSalicylic Acid Cream, 6% Front Label Image

Salicylic Acid Cream, 6% Back Label Image