FDA.reportPublic FDA data

Walgreens 3 Step Acne System

Manufacturer
WALGREEN COMPANY
Effective date
2024-10-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:24:39

Label at a glance#

ProductWalgreens 3 Step Acne System
Active ingredientBENZOYL PEROXIDE
Label structure13 sections

Indications and uses

for the management of acne

Dosage and administration

Sensitivity Test for a New User: Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated below. cover the entire affected area with a thin layer, massaging gently one to two minutes, and rinse thoroughly one to three times daily because excessive drying of the skin may occur, start with one application daily, then gradually increase ...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzoyl Peroxide 2.5%

Purpose

OTC - PURPOSE SECTION

Acne Treatment

Uses

INDICATIONS & USAGE SECTION

for the management of acne

​Warnings

WARNINGS SECTION

For external use only.

Do not use if you

OTC - DO NOT USE SECTION

  • have very sensitive skin
  • are sensitive to benzoyl peroxide.

When using this product

OTC - WHEN USING SECTION

• skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time. • avoid unnecessary sun exposure and use a sunscreen • avoid contact with eyes, lips, and mouth • avoid contact with hair and dyed fabrics, which may be bleached by this product • skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.

​Stop use and ask a doctor if​

OTC - STOP USE SECTION

  • irritation becomes severe.

Keep out of reach of the children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If product is swallowed, get medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

  • Sensitivity Test for a New User: Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated below.
  • cover the entire affected area with a thin layer, massaging gently one to two minutes, and rinse thoroughly one to three times daily
  • because excessive drying of the skin may occur, start with one application daily, then gradually increase to two to three times daily if needed or as directed by a doctor
  • if bothersome dryness or peeling occurs, reduce application to once a day or every other day
  • if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.

Inactive ingredients

INACTIVE INGREDIENT SECTION

WATER, PETROLATUM, CETYL ALCOHOL, HYDROGENATED SOYBEAN OIL, PROPYLENE GLYCOL, BENZYL ALCOHOL, LAURETH-4, POTASSIUM CETYL PHOSPHATE, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, MAGNESIUM ALUMINUM SILICATE, GLYCERYL STEARATE, PEG-100 STEARATE, CETYL ESTERS, STEARETH-2, SORBITOL, SODIUM PCA, ANTHEMIS NOBILIS FLOWER EXTRACT, SODIUM HYALURONATE, DISODIUM EDTA, XANTHAN GUM, TRIDECYL STEARATE, NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE, TRIDECYL TRIMELLITATE, DIMETHYL ISOSORBIDE, FRAGRANCE.

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzoyl Peroxide 2.5%

Purpose

OTC - PURPOSE SECTION

Acne Treatment

Uses

INDICATIONS & USAGE SECTION

for the management of acne

Warnings

WARNINGS SECTION

For external use only.

Do not use this medication if you

OTC - DO NOT USE SECTION

  • have very sensitive skin
  • are sensitive to benzoyl peroxide.

When using this product

OTC - WHEN USING SECTION

• skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time. • avoid unnecessary sun exposure and use a sunscreen •avoid contact with eyes, lips, and mouth • avoid contact with hair and dyed fabrics, which may be bleached by this product • skin irritation may occurs, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • irritation becomes severe.

Keep out of reach of the children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If product is swallowed, get medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

•Sensitivity Test for a New User: Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated below.

  • cleanthe skin thoroughly before applying this product
  • cover the entire affected area with a thin layer one to three times daily
  • because excessive drying of the skin may occur, start with one application daily, then gradually increase to two to three times daily if needed or as directed by a doctor
  • if bothersome dryness or peeling occurs, reduce application to once a day or every other day
  • if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.

Inactive ingredients

INACTIVE INGREDIENT SECTION

WATER, CETEARYL ALCOHOL, PETROLATUM, BENZYL ALCOHOL, POTASSIUM CETYL PHOSPHATE, STEARETH-2, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, PANTHENOL, ALLANTOIN, PROPYLENE GLYCOL, XANTHAN GUM, DIMETHICONE, GLYCERYL STEARATE, PEG-100 STEARATE, CYCLOTETRASILOXANE, CYCLOPENTASILOXANE, ETHOXYDIGLYCOL, FRAGRANCE.

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

W15122K2W15122K2

W15122V1W15122V1

W15111E2W15111E2

W15113E2W15113E2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
845836benzoyl peroxide 2.5 % Medicated Liquid SoapPSN2
200009benzoyl peroxide 2.5 % Topical LotionPSN2
845836benzoyl peroxide 25 MG/ML Medicated Liquid SoapSCD2
200009benzoyl peroxide 25 MG/ML Topical LotionSCD2
845836benzoyl peroxide 2.5 % Medicated Liquid SoapSY2
200009benzoyl peroxide 2.5 % Topical LotionSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a46239a7-5963-4008-8cbb-6b9000f497ebProduct name120250721
b382b4e1-6b48-45f6-bffc-e61b00b0ce19Product name320250317
d9d61457-6a5a-41fc-b418-e5479a2904b7Product name220230303
32012d5c-25ac-49c7-9d4c-1313177fff7cProduct name120230112
13e7e7e3-e885-4c79-af6d-dad1aedbb06eProduct name120220128
4a7d44fe-774d-404b-aad0-8a90fe78375aProduct name420211025
3f45980c-c196-47e5-0e5e-48b7c57327c5Product name520200428
d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27bProduct name320200203
ee5c6de5-d9cd-454f-b250-7b19e5cf2992Product name420190619
ad75fcfd-a339-42a1-9c60-43ba2c654cfaProduct name120170810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-0153-98Walgreens 3 Step Acne System1 in 1 KITKIT12
0363-0162-61Walgreens 3 Step Acne System59 mL in 1 BOTTLELOTION59 mL2.5 g in 100mL2
0363-0167-53Walgreens 3 Step Acne System118 mL in 1 BOTTLELOTION118 mL2.5 g in 100mL2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0153WALGREENS 3 STEP ACNE SYSTEM (BENZOYL PEROXIDE) KIT [WALGREEN COMPANY]2Current NDC, 3 package rows20241013_f7933ecd-4fc7-8526-e053-6394a90a15c5.zip
0363-0162WALGREENS 3 STEP ACNE SYSTEM (BENZOYL PEROXIDE) KIT [WALGREEN COMPANY]2Unmatched20241013_f7933ecd-4fc7-8526-e053-6394a90a15c5.zip
0363-0167WALGREENS 3 STEP ACNE SYSTEM (BENZOYL PEROXIDE) KIT [WALGREEN COMPANY]2Unmatched20241013_f7933ecd-4fc7-8526-e053-6394a90a15c5.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 35 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0363-01530363-0153-98
0363-01670363-0167-53
0363-01620363-0162-61

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 43 matching rows.

Name, UNII, Kind table
NameUNIIKind
STEARETH-2V56DFE46J5IACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
HYDROGENATED SOYBEAN OILA2M91M918CIACT
WATER059QF0KO0RIACT
MAGNESIUM ALUMINUM SILICATE6M3P64V0NCIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PEG-100 STEARATEYD01N1999RIACT
SORBITOL506T60A25RIACT
DIMETHYL ISOSORBIDESA6A6V432SIACT
TRIDECYL STEARATEA8OE252M6LIACT
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATEVLW429K27KIACT
CETYL ESTERS WAXD072FFP9GUIACT
CHAMAEMELUM NOBILE FLOWERO2T154T6OGIACT
HYALURONATE SODIUMYSE9PPT4THIACT
SODIUM PYRROLIDONE CARBOXYLATE469OTG57A2IACT
XANTHAN GUMTTV12P4NEEIACT
TRIDECYL TRIMELLITATEFY36J270ESIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
EDETATE DISODIUM7FLD91C86KIACT
BENZOYL PEROXIDEW9WZN9A0GMACTIB
CETYL ALCOHOL936JST6JCNIACT
PETROLATUM4T6H12BN9UIACT
LAURETH-46HQ855798JIACT
BENZYL ALCOHOLLKG8494WBHIACT
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)809Y72KV36IACT
PANTHENOLWV9CM0O67ZIACT
ALLANTOIN344S277G0ZIACT
XANTHAN GUMTTV12P4NEEIACT
BENZOYL PEROXIDEW9WZN9A0GMACTIB
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)809Y72KV36IACT
BENZYL ALCOHOLLKG8494WBHIACT
PETROLATUM4T6H12BN9UIACT
STEARETH-2V56DFE46J5IACT
WATER059QF0KO0RIACT
DIETHYLENE GLYCOL MONOETHYL ETHERA1A1I8X02BIACT
CYCLOMETHICONE 4CZ227117JEIACT
CYCLOMETHICONE 50THT5PCI0RIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
PROPYLENE GLYCOL6DC9Q167V3IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Walgreens 3 Step Acne SystemBENZOYL PEROXIDEWALGREEN COMPANYf7933ecd-4fc7-8526-e053-6394a90a15c52024-10-11WarningsExact identifier
ndc (package): 0363-0162-61
ndc (package): 0363-0167-53
ndc (package): 0363-0153-98
ndc (product): 0363-0153
ndc11 (package): 00363016261
ndc11 (package): 00363015398
ndc11 (package): 00363016753
spl id: 243ae1cb-052b-f20b-e063-6394a90ad8b7
spl set id: f7933ecd-4fc7-8526-e053-6394a90a15c5

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.