Caldesene

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 However, compound undecylenic acid generally has been replaced by newer and more effective medicines for the treatment of fungus infections.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.

This product is available in the following dosage forms:

• Spray


• Liquid


• Solution


• Cream


• Foam


• Tincture


• Ointment


• Powder

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

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.

Geriatric

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.

Drug Interactions

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 healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use

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 this medicine 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 this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

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

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Store the canister at room temperature, away from heat and direct light. Do not freeze . Do not keep this medicine inside a car where it could be exposed to extreme heat or cold. Do not poke holes in the canister or throw it into a fire, even if the canister is empty .

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions

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.

Side Effects

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 doctor as soon as possible if any of the following side effects occur:

• Skin irritation not present before use of this medicine

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

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.