Undecylenic acid

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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
Undecylenic acid is an antifungal that is FDA approved for the treatment of tinea pedis, tinea corporis.   Common adverse reactions include hypersensitivity.

# Adult Indications and Dosage

## FDA-Labeled Indications and Dosage (Adult)
- Using soap and water, clean the affected area and dry thoroughly.
- Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor.
- Use the brush applicator provided for easy application to the affected area
- For toe usage, change shoes and socks at least once daily and wear well fitting, ventilated shoes.
- Pay particular attention to spaces between the toes for athletes foot.
- For athletes foot and ringworm, use the product daily for 4 weeks. If condition persists longer, consult a physician.
- This product is not effective on the scalp or nails
- Children must be supervised in the use of this product

## Off-Label Use and Dosage (Adult)

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

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

# Pediatric Indications and Dosage

## FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding FDA-Labeled Use of Undecylenic acid in pediatric patients.

## Off-Label Use and Dosage (Pediatric)

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

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

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

# Warnings
- Warnings For external use only.
- Ask a doctor before use on children under 2 years of age
- When using this productavoid contact with the eyes.
- Stop use and consult a doctor if irritation occurs - you do not notice improvement within 4 weeks.
- KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.
- If accidental ingestion occurs, immediately contact a physician, emergency medical facility or Poison Control Center for help.

# Adverse Reactions

## Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Undecylenic acid in the drug label.

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

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

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

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

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

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

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

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

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

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

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

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

# Administration and Monitoring

### Administration
- Topical

### Monitoring
There is limited information regarding Monitoring of Undecylenic acid in the drug label.
- Description

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

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

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

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

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

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

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

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

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

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

# Brand Names
- UNDECYLENIC ACID

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

# Drug Shortage Status

# Price