Undecylenic acid

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Undecylenic acid
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

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

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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)

Directions
  • 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.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-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

Condition1

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

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-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

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

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Template:Chembox header2 | Undecylenic acid
Identifiers
3D model (JSmol)
ChEBI
ChemSpider
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MeSH Undecylenic+acid
UNII
Properties
C11H20O2
Molar mass 184.28 g·mol−1
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 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

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Package and Label Display Panel

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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®[1]

Look-Alike Drug Names

There is limited information regarding Undecylenic acid 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. ↑ "UNDECYLENIC ACID - undecylenic acid liquid".

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