Benzoyl peroxide

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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.

### NonGuideline-Supported Use
Postoperative wound infection; Prophylaxis

# 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.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-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
- Hypersensitivity.
- Erythema.
- Contact dermatitis.

# 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

## 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

## Package and Label Display Panel

# 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 

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

# Drug Shortage Status

# Price