Triclosan

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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
Triclosan is an antiseptic that is FDA approved for the treatment of for hand washing to decrease bacteria on skin.   Common adverse reactions include hypersensitivity.

# Adult Indications and Dosage

## FDA-Labeled Indications and Dosage (Adult)
- For hand washing to decrease bacteria on skin
- Recommended for repeated use

## Off-Label Use and Dosage (Adult)

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

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-Supported Use of Triclosan in adult patients.

# Pediatric Indications and Dosage

## FDA-Labeled Indications and Dosage (Pediatric)
- For hand washing to decrease bacteria on skin
- Recommended for repeated use

## Off-Label Use and Dosage (Pediatric)

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

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-Supported Use of Triclosan in pediatric patients.

# Contraindications
There is limited information regarding Triclosan 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.
- 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 Clinical Trial Experience of Triclosan in the drug label.

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

# Drug Interactions
There is limited information regarding Triclosan 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 Triclosan in women who are pregnant.

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

### Nursing Mothers
There is no FDA guidance on the use of Triclosan with respect to nursing mothers.

### Pediatric Use
There is no FDA guidance on the use of Triclosan with respect to pediatric patients.

### Geriatic Use
There is no FDA guidance on the use of Triclosan with respect to geriatric patients.

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

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

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

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

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

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

# Administration and Monitoring

### Administration
- Topical

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

# IV Compatibility
There is limited information regarding IV Compatibility of Triclosan in the drug label.

# Overdosage
There is limited information regarding Chronic Overdose of Triclosan in the drug label.

# Pharmacology

## Mechanism of Action
- At high concentrations, triclosan acts as a biocide with multiple cytoplasmic and membrane targets. However, at the lower concentrations seen in commercial products, triclosan appears bacteriostatic, and it targets bacteria primarily by inhibiting fatty acid synthesis.
- Triclosan binds to bacterial enoyl-acyl carrier protein reductase (ENR) enzyme, which is encoded by the gene FabI. This binding increases the enzyme's affinity for nicotinamide adenine dinucleotide (NAD+). This results in the formation of a stable, ternary complex of ENR-NAD+-triclosan, which is unable to participate in fatty acid synthesis. Fatty acids are necessary for building and reproducing cell membranes. Humans do not have an ENR enzyme and thus are not affected.

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

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

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

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

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

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

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

# Precautions with Alcohol
- Alcohol-Triclosan interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

# Brand Names
- ANTIBACTERIAL SPRAY

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

# Drug Shortage Status

# Price