NDC Code(s) : 64127-185-01
Packager : Laboratoires dermo Cosmetik Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

GMC Medical Salicylic Acid GEL
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64127-185
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 Acid2000 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
Alcohol(UNII: 3K9958V90M)
Ammonia(UNII: 5138Q19F1X)
Benzalkonium Chloride(UNII: F5UM2KM3W7)
Butylene Glycol(UNII: 3XUS85K0RA)
C12-15 Alkyl Lactate(UNII: GC844VRD7E)
C13-14 Isoparaffin(UNII: E4F12ROE70)
Capryloyl Glycine(UNII: 8TY5YO42NJ)
Cedrus Atlantica Bark(UNII: ITP1Q41UPF)
Cetyl Lactate(UNII: A7EVH2RK4O)
Cinnamon Bark Oil(UNII: XE54U569EC)
Cocamidopropyl Propylene Glycol-Dimonium Chloride Phosphate(UNII: H2KVQ74JM4)
Cyclomethicone 5(UNII: 0THT5PCI0R)
Dehydroxanthan Gum(UNII: 63ZP7I1BQO)
Denatonium Benzoate(UNII: 4YK5Z54AT2)
Glycerin(UNII: PDC6A3C0OX)
Witch Hazel(UNII: 101I4J0U34)
Laureth-7(UNII: Z95S6G8201)
Phenoxyethanol(UNII: HIE492ZZ3T)
Polyacrylamide (1500 MW)(UNII: 5D6TC4BRWV)
Polysorbate 20(UNII: 7T1F30V5YH)
Purslane(UNII: M6S840WXG5)
PPG-2 Isoceteth-20 Acetate(UNII: BI6C7YO419)
Propylene Glycol(UNII: 6DC9Q167V3)
Sarcosine(UNII: Z711V88R5F)
Tert-butyl Alcohol(UNII: MD83SFE959)
Edetate Sodium(UNII: MP1J8420LU)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:64127-185-011 in 1 BOX 02/06/2017
150 g in 1 TUBE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part333D 02/01/2017

PRINCIPAL DISPLAY PANEL

GMC MEDICAL®

ACNE
TREATING GEL

2%
Salicylic Acid

Acne Treatment

NDC 64127-185-01
NPN XXXXXX

50 g - Net wt. 1.8 oz.

PRINCIPAL DISPLAY PANEL - 50 g Tube Box