NDC Code(s) : 49035-264-56
Packager : Walmart, Inc.

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Acne CleanserBenzoyl peroxide CREAM
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-264
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
WATER(UNII: 059QF0KO0R)
CETYL ALCOHOL(UNII: 936JST6JCN)
PETROLATUM(UNII: 4T6H12BN9U)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)(UNII: 59TL3WG5CO)
ZINC LACTATE(UNII: 2GXR25858Y)
STEARETH-2(UNII: V56DFE46J5)
GLYCERIN(UNII: PDC6A3C0OX)
POTASSIUM CETYL PHOSPHATE(UNII: 03KCY6P7UT)
XANTHAN GUM(UNII: TTV12P4NEE)
BENZYL ALCOHOL(UNII: LKG8494WBH)
EDETATE DISODIUM ANHYDROUS(UNII: 8NLQ36F6MM)
LAURETH-4(UNII: 6HQ855798J)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
LACTIC ACID(UNII: 33X04XA5AT)
MENTHOL(UNII: L7T10EIP3A)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:49035-264-56141 g in 1 TUBE Type 0: Not a Combination Product18/02/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M006 02/18/2014

LABELER - Walmart, Inc.(051957769)

REGISTRANT - Nice-Pak Products, LLC(119091520)

Establishment
Name Address ID/FEI Business Operations
Nice-Pak Products, LLC 119091514 manufacture(49035-264)

PRINCIPAL DISPLAY PANEL

  • NDC 49035-264-56

equate™

DAILY ACNE CONTROL CLEANSER

Benzoyl Peroxide 10% Acne Medication

For Acne-Prone Skin

Paraben-Free

  • Keeps fighting acne even after you wash

NET WT 5 OZ (141 g)

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