NDC Code(s) : 72288-821-99
Packager : Amazon.com Services LLC

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Acne ScrubSalicylic Acid GEL
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:72288-821
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 ACID20 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
SODIUM C14-16 OLEFIN SULFONATE(UNII: O9W3D3YF5U)
COCAMIDOPROPYL BETAINE(UNII: 5OCF3O11KX)
GLYCERIN(UNII: PDC6A3C0OX)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW)(UNII: JZ1374NL9E)
POWDERED CELLULOSE(UNII: SMD1X3XO9M)
POLYSORBATE 20(UNII: 7T1F30V5YH)
C12-15 ALKYL LACTATE(UNII: GC844VRD7E)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
EDETATE DISODIUM(UNII: 7FLD91C86K)
BENZALKONIUM CHLORIDE(UNII: F5UM2KM3W7)
POLYVINYL ALCOHOL, UNSPECIFIED(UNII: 532B59J990)
COCAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE PHOSPHATE(UNII: H2KVQ74JM4)
SULISOBENZONE(UNII: 1W6L629B4K)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
PUMMELO(UNII: ET1TN5W71X)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE(UNII: VLW429K27K)
CARRAGEENAN(UNII: 5C69YCD2YJ)
AGAR, UNSPECIFIED(UNII: 89T13OHQ2B)
ASCORBYL PALMITATE(UNII: QN83US2B0N)
MICA(UNII: V8A1AW0880)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
D&C RED NO. 30(UNII: 2S42T2808B)
FD&C RED NO. 40(UNII: WZB9127XOA)
EXT. D&C VIOLET NO. 2(UNII: G5UX3K0728)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:72288-821-99124 mL in 1 TUBE Type 0: Not a Combination Product25/04/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M006 04/25/2018

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(72288-821)

PRINCIPAL DISPLAY PANEL

amazone essentials

Grapefruit Acne Scrub

Exfoliating

2% salicylic acid acne medication

Helps prevent the development of new acne pimples

4.2 FL OZ (124 mL)

image description

PRINCIPAL DISPLAY PANEL

amazon basics

Acne Scrub

SALICYLIC ACID ACNE MEDICATION

Pink Grapefruit

4.2 FL OZ (124 mL)

image description