NDC Code(s) : 42808-301-14
Packager : Exact-Rx, 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:42808-301
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 ACID60 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
TROLAMINE(UNII: 9O3K93S3TK)
WATER(UNII: 059QF0KO0R)
METHYLPARABEN(UNII: A2I8C7HI9T)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
PEG-100 STEARATE(UNII: YD01N1999R)
CETYL ALCOHOL(UNII: 936JST6JCN)
MINERAL OIL(UNII: T5L8T28FGP)
GLYCERYL 1-STEARATE(UNII: 258491E1RZ)
DIMETHICONE 350(UNII: 2Y53S6ATLU)
AMMONIUM LACTATE(UNII: 67M901L9NQ)
EDETATE DISODIUM(UNII: 7FLD91C86K)
GLYCERIN(UNII: PDC6A3C0OX)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
POLYSORBATE 60(UNII: CAL22UVI4M)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:42808-301-14400 g in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 08/01/2011

PRINCIPAL DISPLAY PANEL

For External Use Only

NDC 42808-0301-14        Rx Only

Salicylic
Acid

6%

LOTION

Exact-Rx.
INCORPORATED

Net Wt. 14 oz (400 g)

00-301-14-200-00

SA 6% Lotion