Chloroxylenol

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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
Chloroxylenol is an antibacterial that is FDA approved for the procedure of hand washing to decrease bacteria on the skin.   Common adverse reactions include irritation and redness.

# Adult Indications and Dosage

## FDA-Labeled Indications and Dosage (Adult)
- Wet hands and forearms
- Apply 5 milliliters (teaspoonful) or palmful to hands and forearms
- Scrub thoroughly for 1 minute and rinse

## Off-Label Use and Dosage (Adult)

### Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Sodium oxybate (patient information) in adult patients.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-Supported Use of Sodium oxybate (patient information) in adult patients.

# Pediatric Indications and Dosage

## FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Chloroxylenol FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

## Off-Label Use and Dosage (Pediatric)

### Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Sodium oxybate (patient information) in pediatric patients.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-Supported Use of Sodium oxybate (patient information) in pediatric patients.

# Contraindications
There is limited information regarding Chloroxylenol Contraindications in the drug label.

# Warnings
- For external use only.
- When using this product:
Avoid contact with eyes.
In case of eye contact, flush eyes with water.
- Avoid contact with eyes.
- In case of eye contact, flush eyes with water.
- Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.
- 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 Chloroxylenol Clinical Trials Experience in the drug label.

## Postmarketing Experience
There is limited information regarding Chloroxylenol Postmarketing Experience in the drug label.

# Drug Interactions
There is limited information regarding Chloroxylenol Drug Interactions in the drug label.

# Use in Specific Populations

### Pregnancy
Pregnancy Category (FDA): 
There is no FDA guidance on usage of Chloroxylenol in women who are pregnant.
Pregnancy Category (AUS): 
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Chloroxylenol in women who are pregnant.

### Labor and Delivery
There is no FDA guidance on use of Chloroxylenol during labor and delivery.

### Nursing Mothers
There is no FDA guidance on the use of Chloroxylenol in women who are nursing.

### Pediatric Use
There is no FDA guidance on the use of Chloroxylenol in pediatric settings.

### Geriatic Use
There is no FDA guidance on the use of Chloroxylenol in geriatric settings.

### Gender
There is no FDA guidance on the use of Chloroxylenol with respect to specific gender populations.

### Race
There is no FDA guidance on the use of Chloroxylenol with respect to specific racial populations.

### Renal Impairment
There is no FDA guidance on the use of Chloroxylenol in patients with renal impairment.

### Hepatic Impairment
There is no FDA guidance on the use of Chloroxylenol in patients with hepatic impairment.

### Females of Reproductive Potential and Males
There is no FDA guidance on the use of Chloroxylenol in women of reproductive potentials and males.

### Immunocompromised Patients
There is no FDA guidance one the use of Chloroxylenol in patients who are immunocompromised.

# Administration and Monitoring

### Administration
There is limited information regarding Chloroxylenol Administration in the drug label.

### Monitoring
There is limited information regarding Chloroxylenol Monitoring in the drug label.

# IV Compatibility
There is limited information regarding the compatibility of Chloroxylenol and IV administrations.

# Overdosage
There is limited information regarding Chloroxylenol 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 Chloroxylenol Mechanism of Action in the drug label.

## Structure
There is limited information regarding Chloroxylenol Structure in the drug label.

## Pharmacodynamics
There is limited information regarding Chloroxylenol Pharmacodynamics in the drug label.

## Pharmacokinetics
There is limited information regarding Chloroxylenol Pharmacokinetics in the drug label.

## Nonclinical Toxicology
There is limited information regarding Chloroxylenol Nonclinical Toxicology in the drug label.

# Clinical Studies
There is limited information regarding Chloroxylenol Clinical Studies in the drug label.

# How Supplied
There is limited information regarding Chloroxylenol How Supplied in the drug label.

## Storage
There is limited information regarding Chloroxylenol Storage in the drug label.

# Images

## Drug Images

## Package and Label Display Panel

# Patient Counseling Information
There is limited information regarding Chloroxylenol Patient Counseling Information in the drug label.

# Precautions with Alcohol
Alcohol-Sodium oxybate (patient information) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

# Brand Names
- Xyrem

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

# Drug Shortage Status

# Price