In the U.S.—

In Canada—

• Antifungal, topical

Compound undecylenic acid (un-de-sill-ENN-ik AS-id) belongs to the group of medicines called antifungals. It is used to treat some types of fungus infections. However, compound undecylenic acid generally has been replaced by newer and more effective medicines for the treatment of fungus infections.

Compound undecylenic acid is available without a prescription; however, your doctor may have special instructions on the proper use of this medicine for your medical condition.

Compound undecylenic acid is available in the following dosage forms:

Topical
• Aerosol foam (U.S. and Canada)
• Aerosol powder (U.S. and Canada)
• Cream (U.S. and Canada)
• Ointment (U.S. and Canada)
• Powder (U.S. and Canada)
• Solution (U.S. and Canada)

If you are taking this medicine without a prescription, carefully read and follow any precautions on the label. For compound undecylenic acid, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to compound undecylenic acid. Also tell your health care professional if you are allergic to any other substances, such as preservatives or dyes.

Pregnancy—Compound undecylenic acid topical preparations have not been shown to cause birth defects or other problems in humans.

Breast-feeding—Compound undecylenic acid topical preparations have not been reported to cause problems in nursing babies.

Children—Compound undecylenic acid should not be used on children up to 2 years of age, unless otherwise directed by your doctor. Although there is no specific information comparing use of compound undecylenic acid topical preparations in children 2 years of age and older with use in other age groups, this medicine is not expected to cause different side effects or problems in children 2 years of age and older than it does in adults.

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of compound undecylenic acid in the elderly with use in other age groups.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your health care professional if you are using any other topical prescription or nonprescription (over-the-counter [OTC]) medicine that is to be applied to the same area of the skin.

Before applying compound undecylenic acid, wash the affected and surrounding areas, and dry thoroughly. Then apply enough medicine to cover these areas.

Keep this medicine away from the eyes.

For patients using the cream form of this medicine:

• Apply cream generously to affected and surrounding areas. Rub in well.
• Do not use on pus-containing sores or on badly broken skin.

For patients using the powder form of this medicine:

• If the powder is used on the feet, sprinkle it between toes, on feet, and in socks and shoes.

For patients using the aerosol powder or aerosol foam form of this medicine:

• From a distance of 4 to 6 inches, spray the affected and surrounding areas. If the medicine is used on the feet, spray it between the toes also. The powder may also be sprayed in socks and shoes.
• Do not use this medicine around the eyes, nose, or mouth.
• Do not inhale the aerosol.
• Do not use near heat, near open flame, or while smoking.

To help clear up your infection completely, keep using this medicine for 2 weeks after burning, itching, or other symptoms have disappeared , unless otherwise directed by your doctor. Do not miss any doses.

Dosing—

The dose of topical compound undecylenic acid will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of topical compound undecylenic acid. If your dose is different, do not change it unless your doctor tells you to do so.

• For fungus infections:
  • For aerosol foam, aerosol powder, ointment, powder, or solution dosage forms:
    • Adults and children 2 years of age and over—Apply to the affected area(s) of the skin two times a day.
    • Children up to 2 years of age—Use is not recommended.
  • For cream dosage form:
    • Adults and children—Apply to the affected area(s) of the skin as often as necessary.

Missed dose—

If you miss a dose of this medicine, apply it as soon as possible. Then go back to your regular dosing schedule.

Storage—

To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store the powder form of this medicine in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Keep the aerosol foam, aerosol powder, cream, ointment, and solution forms of this medicine from freezing.
• Do not puncture, break, or burn the aerosol foam or powder container.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

If your skin problem does not improve within 4 weeks, or if it becomes worse, check with your health care professional.

To help prevent reinfection after the period of treatment with this medicine, the powder or spray powder form of this medicine may be used each day after bathing and careful drying.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your health care professional as soon as possible if the following side effect occurs:

• Skin irritation not present before use of this medicine 

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your health care professional.