NDC Code(s) : 33992-8815-1
Packager : Greenbrier International, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ACNE FIGHTING ROLL ON GELSALICYLIC ACID GEL
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:33992-8815
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 ACID2 g in 100 g
Inactive Ingredients
Ingredient Name Strength
ALCOHOL(UNII: 3K9958V90M)
ALLANTOIN(UNII: 344S277G0Z)
GLYCERIN(UNII: PDC6A3C0OX)
HYDROXYETHYL CELLULOSE (3000 MPA.S AT 1%)(UNII: 7Q6P4JN1QT)
METHYLISOTHIAZOLINONE(UNII: 229D0E1QFA)
POLYSORBATE 20(UNII: 7T1F30V5YH)
WATER(UNII: 059QF0KO0R)
Product Characteristics
Color white Score
Shape ROUND Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:33992-8815-19.4 g in 1 TUBE, WITH APPLICATOR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333D 07/15/2014

PRINCIPAL DISPLAY PANEL

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