Clearasil Stubborn Acne Control 5in1 Spot Treatment

BENZOYL PEROXIDE TOPICAL HUMAN OTC DRUG

Clearasil Stubborn Acne Control 5in1 Spot Treatment is an FDA drug label for the active ingredient BENZOYL PEROXIDE manufactured by Reckitt Benckiser LLC administered by TOPICAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20260513.

Generic name
BENZOYL PEROXIDE
Manufacturer
Reckitt Benckiser LLC
Product type
HUMAN OTC DRUG
Route
TOPICAL
Dosage form
N/A
NDC
63824-438
Application
M006
Label effective
20260513

About this product

Clearasil Stubborn Acne Control 5in1 Spot Treatment is an FDA-registered drug product whose active ingredient is BENZOYL PEROXIDE. It is labelled by Reckitt Benckiser LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 63824-438, application M006, label effective 20260513. It is one of 56 FDA drug label records sharing the active ingredient BENZOYL PEROXIDE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

What it is used for

Across FDA labelling, products containing BENZOYL PEROXIDE are most often described in connection with: treatment acne. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

Active ingredient Benzoyl peroxide 10%

Indications & Usage

Use for the treatment of acne

Dosage & Administration

Directions 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.

Warnings

Warnings For external use only Do not use if you have very sensitive skin are sensitive to benzoyl peroxide When using this product 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. Stop use and ask a doctor if irritation becomes severe Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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How products containing BENZOYL PEROXIDE compare

FDA lists 56 drug label records with BENZOYL PEROXIDE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

Dosage formProductsManufacturerProducts
— — AcneFree, LLC 5
— — Topiderm, Inc. 5
— — CVS Health 4
— — Face Reality, LLC 3
— — Apprendista, LLC 2

Recall and safety notices

5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

RecallProductFirmClassStatusReported
D-1517-2016 Mucinex Sinus-Max Day Night, 60 caplets, Dist. by Reckitt Benckiser, Parsippany, NJ 07054-0224 UPC 363824951737 NDC 63824-207-60 Reckitt Benckiser LLC Class III Terminated 20160928
D-1363-2015 Mucinex Fast Max Cold, Flu & Sore Throat, Maximum Strength, Acetaminophen Pain Reliever/Fever Reducer, Dextromethorphan HBr Cough Suppressant, Guaifenesin Expectorant, Phenylephrine HCl Nasal Decongestant, 6 fl oz (180 mL) Bottle, For Ages 12+, , Dist. By: Reckitt Benckiser Parsippany, NJ 07054-0224 Made in India, NDC 63824-015-66, UPC 63824-01565-1 Reckitt Benckiser LLC Class I Terminated 20150902
D-1365-2015 Mucinex Fast-Max Cold & Sinus, Maximum Strength, Acetaminophen Pain Reliever/Fever Reducer, Guaifenesin Expectorant, Phenylephrine HCl Nasal Decongestant, 6 fl oz (180 mL) Bottle, For Ages 12+, Dist. by: Reckitt Benckiser Parsippany, NJ 07054-0224 Made in India, NDC 63824-016-66, UPC 63824-01665-8 Reckitt Benckiser LLC Class I Terminated 20150902
D-1367-2015 Mucinex Fast Max Severe Congestion & Cough, Maximum Strength, Dextromethorphan HBr Cough Suppressant, Guaifenesin Expectorant, Phenylephrine HCl Nasal Decongestant, 6 fl oz (180 mL) Bottle, For Age 12+, Dist. By: Reckitt Benckiser Parsippany, NJ 07054-0224, Made in India, NDC 63824-014-66, UPC 6382401465-4 Reckitt Benckiser LLC Class I Terminated 20150902
D-1368-2015 Mucinex Fast Max Day Time Severe Congestion & Cough Night Time Cold & Flu, Maximum Strength, Two - 6 fl oz (180 mL) bottles Total - 12 fl oz (360 mL), For Ages 12+, Dist. by Reckitt Benckiser Parsippany, NJ 07054-0224, Made in India, NDC 63824-528-22-01, NDC 63824-528-22-00, UPC 63824-52822-9 Reckitt Benckiser LLC Class I Terminated 20150902

Frequently asked questions

What is Clearasil Stubborn Acne Control 5in1 Spot Treatment used for?
Use for the treatment of acne

Who makes Clearasil Stubborn Acne Control 5in1 Spot Treatment?
Reckitt Benckiser LLC is the labeler of record for Clearasil Stubborn Acne Control 5in1 Spot Treatment. 56 FDA label records share the active ingredient BENZOYL PEROXIDE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Clearasil Stubborn Acne Control 5in1 Spot Treatment come in?
administered by topical. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Clearasil Stubborn Acne Control 5in1 Spot Treatment prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing BENZOYL PEROXIDE?
Yes. 56 FDA drug label records list BENZOYL PEROXIDE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Clearasil Stubborn Acne Control 5in1 Spot Treatment been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.

This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.