FDA.reportPublic FDA data

Clearasil ® Stubborn Acne Control 5in1 Spot Treatment Cream

Manufacturer
Reckitt Benckiser LLC
Effective date
2026-05-13
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:57:44

Label at a glance#

ProductClearasil Stubborn Acne Control 5in1 Spot Treatment
Active ingredientBENZOYL PEROXIDE
Label structure11 sections

Dosage and administration

clean the 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 or 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 ...

Storage and handling

keep outer box for full product information keep tightly closed store at 20-25 °C (68-77 °F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzoyl peroxide 10%

Purpose

OTC - PURPOSE SECTION

Acne medication

Use

INDICATIONS & USAGE SECTION

for the treatment of acne

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not useif you

  • have very sensitive skin
  • are sensitive to benzoyl peroxide

When using this product

OTC - WHEN USING SECTION

  • avoid unnecessary sun exposure and use a sunscreen
  • avoid contact with the eyes, lips and mouth
  • avoid contact with hair and dyed fabrics, which may be bleached by this product
  • 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.
  • 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.

OTC - STOP USE SECTION

Stop use and ask a doctor ifirritation becomes severe

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • clean the 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 or 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.

Other information

STORAGE AND HANDLING SECTION

  • keep outer box for full product information
  • keep tightly closed
  • store at 20-25 °C (68-77 °F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Propylene Glycol, Aluminum Hydroxide, Bentonite, Glyceryl Stearate SE, PEG-12, Isopropyl Myristate, Methylparaben, Carbomer, Potassium Hydroxide, Propylparaben

Questions?

OTC - QUESTIONS SECTION

1-866-25-CLEAR (1-866-252-5327).You may also report side effects to this phone number.

SPL UNCLASSIFIED SECTION

Distributed By:
RB Health (US),
Parsippany, NJ 07054-0224

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Clearasil ®

STUBBORN ACNE CONTROL
5IN1 SPOT TREATMENT CREAM

Benzoyl Peroxide Acne Medication

FIGHTS
5
STUBBORN
ACNE
PROBLEMS

MAXIMUM STRENGTH

FIGHTS 1. BLOCKED PORES 2. PIMPLE SIZE
3. EXCESS OIL 4. ACNE MARKS 5. BLACKHEADS

Net wt. 1 oz (28 g)

Principal Display Panel - 28 g Tube Carton
Principal Display Panel - 28 g Tube Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
106315benzoyl peroxide 10 % Topical CreamPSN5
106315benzoyl peroxide 100 MG/ML Topical CreamSCD5
106315benzoyl peroxide 10 % Topical CreamSY5

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeData Matrix8354047clearasilsac-01.jpg

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
63824-438-01Clearasil Stubborn Acne Control 5in1 Spot Treatment1 in 1 CARTONCREAM15
63824-438-01Clearasil Stubborn Acne Control 5in1 Spot Treatment28 g in 1 TUBECREAM285

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63824-43863824-438-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
BENTONITEA3N5ZCN45CIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
POLYETHYLENE GLYCOL 600NL4J9F21N9IACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
METHYLPARABENA2I8C7HI9TIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
POTASSIUM HYDROXIDEWZH3C48M4TIACT
PROPYLPARABENZ8IX2SC1OHIACT
BENZOYL PEROXIDEW9WZN9A0GMACTIB

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
Clearasil Stubborn Acne Control 5in1 Spot TreatmentBENZOYL PEROXIDEReckitt Benckiser LLCbdb87e60-67a6-4c0e-b0ab-3e238a08269c2026-05-13WarningsExact identifier
ndc (package): 63824-438-01
ndc (product): 63824-438
ndc11 (package): 63824043801
spl id: 51b5eaa5-c7c5-24e3-e063-6394a90abe52
spl set id: bdb87e60-67a6-4c0e-b0ab-3e238a08269c

Reported adverse events (FAERS/openFDA)#

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