NDC Code(s) : 58400-009-01, 58400-009-02
Packager : Pharmco Laboratories Inc.

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Benzoyl Peroxide CleanserBenzoyl Peroxide GEL
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:58400-009
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Benzoyl Peroxide(UNII: W9WZN9A0GM)
(Benzoyl Peroxide - UNII:W9WZN9A0GM) 		Benzoyl Peroxide35 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
Water(UNII: 059QF0KO0R)
SODIUM C12-14 OLEFIN SULFONATE(UNII: 7I962MCQ71)
Disodium Cocoamphodiacetate(UNII: 18L9G3U51M)
Glycerin(UNII: PDC6A3C0OX)
Propylene Glycol(UNII: 6DC9Q167V3)
PERLITE(UNII: 0SG101ZGK9)
Allantoin(UNII: 344S277G0Z)
Panthenol(UNII: WV9CM0O67Z)
Hyaluronate Sodium(UNII: YSE9PPT4TH)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)(UNII: 59TL3WG5CO)
Edetate Disodium(UNII: 7FLD91C86K)
Phenoxyethanol(UNII: HIE492ZZ3T)
Ethylhexylglycerin(UNII: 147D247K3P)
Sodium Hydroxide(UNII: 55X04QC32I)
FD&C Yellow NO. 5(UNII: I753WB2F1M)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:58400-009-01170 g in 1 BOTTLE, DISPENSING Type 0: Not a Combination Product12/01/2016
2NDC:58400-009-023900 g in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product12/01/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph drug M006 12/01/2016

LABELER - Pharmco Laboratories Inc.(096270814)

Establishment
Name Address ID/FEI Business Operations
Pharmco Laboratories Inc. 096270814 MANUFACTURE(58400-009), LABEL(58400-009), PACK(58400-009), ANALYSIS(58400-009)

PRINCIPAL DISPLAY PANEL

PHARMCO
SKINCARE LABS

Benzoyl Peroxide
Cleansing Gel 3.5%

Net wt. 6 oz. (170 g)

PRINCIPAL DISPLAY PANEL - 170 g Bottle Label