NDC Code(s) : 72288-229-10
Packager : Amazon.com Services LLC

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Acne TreatmentBenzoyl peroxide GEL
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:72288-229
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 PEROXIDE100 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE(UNII: 0A5MM307FC)
EDETATE DISODIUM(UNII: 7FLD91C86K)
HYPROMELLOSES(UNII: 3NXW29V3WO)
LAURETH-4(UNII: 6HQ855798J)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:72288-229-101 in 1 PACKAGE 22/03/2019
128 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 Drug M006 03/22/2019

LABELER - Amazon.com Services LLC(128990418)

REGISTRANT - Nice-Pak Products, LLC(119091520)

Establishment
Name Address ID/FEI Business Operations
Nice-Pak Products, LLC 119091514 manufacture(72288-229)

PRINCIPAL DISPLAY PANEL

amazon basics

10% benzoyl peroxide

acne medication

Dermatologist Tested

for Treatment of Acne

Compare to Clean & Clear ® Persa-Gel ®10 Maximum Strength*

NET WT 1 OZ (28 g)

image description

PRINCIPAL DISPLAY PANEL

Solimo

10% Benzoyl Peroxide

Acne Medication

MAXIMUM STRENGTH

Dermatologitsted For treatment of acne

NET WT 1 OZ (28 g)

image description