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Benzoyl peroxide

From Wikidoc - Reading time: 6 min

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Ammu Susheela, M.D. [2]

Disclaimer

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NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Overview

Benzoyl peroxide is an antiseptic that is FDA approved for the treatment of acne. Common adverse reactions include hypersensitivity, contact dermatitis, erythema.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

  • For the treatment of acne

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Benzoyl peroxide in adult patients.

Non–Guideline-Supported Use

Postoperative wound infection; Prophylaxis[1]

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Benzoyl peroxide in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Benzoyl peroxide in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Benzoyl peroxide in pediatric patients.

Contraindications

There is limited information regarding Benzoyl peroxide Contraindications in the drug label.

Warnings

  • For external use only
  • Do not use if you have very sensitive skin are sensitive to benzoyl peroxide
  • When using 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.
  • 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 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.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Benzoyl peroxide in the drug label.

Postmarketing Experience

Drug Interactions

There is limited information regarding Benzoyl peroxide Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • Pregnancy Category


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Benzoyl peroxide in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Benzoyl peroxide during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Benzoyl peroxide with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Benzoyl peroxide with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Benzoyl peroxide with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Benzoyl peroxide with respect to specific gender populations.

Race

There is no FDA guidance on the use of Benzoyl peroxide with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Benzoyl peroxide in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Benzoyl peroxide in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Benzoyl peroxide in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Benzoyl peroxide in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Topical

Monitoring

There is limited information regarding Monitoring of Benzoyl peroxide in the drug label.

IV Compatibility

There is limited information regarding IV Compatibility of Benzoyl peroxide in the drug label.

Overdosage

There is limited information regarding Benzoyl peroxide overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

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Template:Chembox header2 | Benzoyl peroxide
Identifiers
3D model (JSmol)
ChEMBL
ChemSpider
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KEGG
UNII
Properties
C14H10O4
Molar mass 242.23 g·mol−1
Hazards
Template:Chembox header2 | Except where noted otherwise, data are given for
materials in their standard state
(at 25 °C, 100 kPa)
Infobox disclaimer and references

Mechanism of Action

There is limited information regarding Benzoyl peroxide Mechanism of Action in the drug label.

Structure

There is limited information regarding Benzoyl peroxide Structure in the drug label.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Benzoyl peroxide in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Benzoyl peroxide in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Benzoyl peroxide in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Benzoyl peroxide in the drug label.

How Supplied

There is limited information regarding Benzoyl peroxide How Supplied in the drug label.

Storage

There is limited information regarding Benzoyl peroxide Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

This image is provided by the National Library of Medicine.
This image is provided by the National Library of Medicine.

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Benzoyl peroxide in the drug label.

Precautions with Alcohol

  • Alcohol-Benzoyl peroxide interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

  • GLYTONE ACNE ®[2]

Look-Alike Drug Names

There is limited information regarding Benzoyl peroxide Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

  1. ↑ Bencini PL, Galimberti M, Signorini M (1994). "Utility of topical benzoyl peroxide for prevention of surgical skin wound infection". J Dermatol Surg Oncol. 20 (8): 538–40. PMID 8056888.
  2. ↑ "GLYTONE ACNE- benzoyl peroxide gel".
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