NDC Code(s) : 41163-821-99
Packager : United Natural Foods, Inc. dba UNFI

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:41163-821
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)
GLYCERIN(UNII: PDC6A3C0OX)
COCAMIDOPROPYL BETAINE(UNII: 5OCF3O11KX)
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW)(UNII: JZ1374NL9E)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POWDERED CELLULOSE(UNII: SMD1X3XO9M)
CARRAGEENAN(UNII: 5C69YCD2YJ)
C12-15 ALKYL LACTATE(UNII: GC844VRD7E)
EDETATE DISODIUM ANHYDROUS(UNII: 8NLQ36F6MM)
COCAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE PHOSPHATE(UNII: H2KVQ74JM4)
PUMMELO(UNII: ET1TN5W71X)
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD)(UNII: 0L414VCS5Y)
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
ASCORBYL PALMITATE(UNII: QN83US2B0N)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE(UNII: VLW429K27K)
CHAMAEMELUM NOBILE FLOWER(UNII: O2T154T6OG)
POLYSORBATE 20(UNII: 7T1F30V5YH)
POLYVINYL ALCOHOL, UNSPECIFIED(UNII: 532B59J990)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
BENZALKONIUM CHLORIDE(UNII: F5UM2KM3W7)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
SODIUM BENZOTRIAZOLYL BUTYLPHENOL SULFONATE(UNII: 0LA2QC9O3Z)
AGAR(UNII: 89T13OHQ2B)
MICA(UNII: V8A1AW0880)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
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:41163-821-99124 mL in 1 TUBE Type 0: Not a Combination Product26/02/2013
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M006 02/26/2013

LABELER - United Natural Foods, Inc. dba UNFI(943556183)

REGISTRANT - Nice-Pak Products, LLC(119091520)

Establishment
Name Address ID/FEI Business Operations
Nice-Pak Products, LLC 119091514 manufacture(41163-821)

PRINCIPAL DISPLAY PANEL

EQUALINE ®

Compare to Neutrogena ®Oil-Free Acne Wash Pink Grapefruit Foaming Scrub*

Oil-Free

Acne Scrub

Pink Grapefruit

Salicylic Acid Acne Treatment

Helps Fight Breakouts

Contains Naturally Derived Grapefruit Extract

4.2 FL OZ (124 mL)

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