Akurza Topical

This section provides information on the proper use of a number of products that contain salicylic acid. It may not be specific to Akurza. Please read with care.

Use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than recommended on the label, unless otherwise directed by your doctor. To do so may increase the chance of absorption through the skin and the chance of salicylic acid poisoning.

This medicine is for use only on the skin. Do not get any of it in your eyes, nose, or mouth . Rinse it off with water right away if it does get on these areas.

Before using an OTC acne product for the first time, apply a small amount to one or two small affected areas of the skin for 3 days. If no discomfort occurs, follow the directions on the drug facts label of the product.

If your doctor has ordered an occlusive dressing (airtight covering, such as kitchen plastic wrap) to be applied over this medicine, make sure you know how to apply it. Since an occlusive dressing will increase the amount of medicine absorbed through your skin and the possibility of salicylic acid poisoning, use it only as directed. If you have any questions about this, check with your doctor.

Keep this medicine away from the eyes and other mucous membranes, such as the mouth and inside of the nose. If you should accidentally get some in your eyes or on other mucous membranes, immediately flush them with water for 15 minutes.

To use the cream, lotion, or ointment:

• Apply enough medicine to cover the affected area, and rub in gently.

To use the gel:

• Before using salicylic acid gel, apply wet packs to the affected areas for at least 5 minutes. If you have any questions about this, check with your doctor.
• Apply enough gel to cover the affected areas, and rub in gently.

To use the pad:

• Wipe the pad over the affected areas.
• Do not rinse off medicine after treatment.

To use the plaster for warts, corns, or calluses:

• This medicine comes with patient instructions. Read them carefully before using.
• Do not use this medicine on irritated skin or on any area that is infected or reddened. Also, do not use this medicine if you are a diabetic or if you have poor blood circulation.
• Do not use this medicine on warts with hair growing from them or on warts on the face, in or on the genital (sex) organs, or inside the nose or mouth. Also do not use on moles or birthmarks. To do so may cause severe irritation.
• Wash the area to be treated and dry thoroughly. Warts may be soaked in warm water for 5 minutes before drying.
• Cut the plaster to fit the wart, corn, or callus and apply.
• For corns and calluses:
  • Repeat every 48 hours as needed for up to 14 days, or as directed by your doctor, until the corn or callus is removed.
  • Corns or calluses may be soaked in warm water for 5 minutes to help in their removal.
• For warts:
  • Depending on the product, either:
    • Apply plaster and repeat every 48 hours as needed, or
      • Apply plaster at bedtime, leave in place for at least 8 hours, remove plaster in the morning, and repeat every 24 hours as needed.
  • Repeat for up to 12 weeks as needed, or as directed by your doctor, until wart is removed.
• If discomfort gets worse during treatment or continues after treatment, or if the wart spreads, check with your doctor.

To use the shampoo:

• Before applying this medicine, wet the hair and scalp with lukewarm water. Apply enough medicine to work up a lather and rub well into the scalp for 2 or 3 minutes, then rinse. Apply the medicine again and rinse thoroughly.

To use the soap:

• Work up a lather with the soap, using hot water, and scrub the entire affected area with a washcloth or facial sponge or mitt.
• If you are to use this soap in a foot bath, work up rich suds in hot water and soak the feet for 10 to 15 minutes. Then pat dry without rinsing.

To use the topical solution:

• Wet a cotton ball or pad with the topical solution and wipe the affected areas.
• Do not rinse off medicine after treatment.

To use the topical solution for warts, corns, or calluses:

• This medicine comes with patient instructions. Read them carefully before using.
• This medicine is flammable. Do not use it near heat or open flame or while smoking.
• Do not use this medicine on irritated skin or on any area that is infected or reddened. Also, do not use this medicine if you are a diabetic or if you have poor blood circulation.
• Do not use this medicine on warts with hair growing from them or on warts on the face, in or on the genital (sex) organs, or inside the nose or mouth. Also do not use on moles or birthmarks. To do so may cause severe irritation.
• Avoid breathing in the vapors from the medicine.
• Wash the area to be treated and dry thoroughly. Warts may be soaked in warm water for 5 minutes before drying.
• Apply the medicine one drop at a time to completely cover each wart, corn, or callus. Let dry.
• For warts—Repeat one or two times a day as needed for up to 12 weeks, or as directed by your doctor, until wart is removed.
• For corns and calluses—Repeat one or two times a day as needed for up to 14 days, or as directed by your doctor, until the corn or callus is removed.
• Corns and calluses may be soaked in warm water for 5 minutes to help in their removal.
• If discomfort gets worse during treatment or continues after treatment, or if the wart spreads, check with your doctor.

Unless your hands are being treated, wash them immediately after applying this medicine to remove any medicine that may be on them.

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 topical dosage form (cream):
  • For corns and calluses:
    • Adults—Use the 2 to 10% cream as needed. Use the 25 to 60% cream once every 3 to 5 days.
    • Children 2 years of age and older—Use the 2 to 10% cream as needed. Use the 25 to 60% cream once every 3 to 5 days.
    • Children younger than 2 years of age—Use is not recommended.
• For topical dosage form (gel):
  • For acne:
    • Adults—Use the 0.5 to 5% gel once a day.
    • Children 2 years of age and older—Use the 0.5 to 5% gel once a day.
    • Children younger than 2 years of age—Use is not recommended.
  • For psoriasis:
    • Adults—Use the 5% gel once a day.
    • Children 2 years of age and older—Use the 5% gel once a day.
    • Children younger than 2 years of age—Use is not recommended.
  • For common warts:
    • Adults—Use the 5 to 26% gel one time a day.
    • Children 2 years of age and older—Use the 5 to 26% gel one time a day.
    • Children younger than 2 years of age—Use is not recommended.
• For topical dosage form (lotion):
  • For acne:
    • Adults—Use the 1 to 2% lotion one to three times a day.
    • Children 2 years of age and older—Use the 1 to 2% lotion one to three times a day
    • Children younger than 2 years of age—Use is not recommended.
  • For dandruff and antiseborrhic dermatitis of the scalp:
    • Adults—Use the 1.8 to 2% lotion on the scalp one or two times a day.
    • Children 2 years of age and older—Use the 1.8 to 2% lotion on the scalp one or two times a day.
    • Children younger than 2 years of age—Use is not recommended.
• For topical dosage form (ointment):
  • For acne:
    • Adults—Use the 3 to 6% ointment as needed.
    • Children 2 years of age and older—Use the 3 to 6% ointment as needed.
    • Children younger than 2 years of age—Use is not recommended.
  • For psoriasis and seborrheic dermatitis:
    • Adults—Use the 3 to 10% ointment as needed.
    • Children 2 years of age and older—Use the 3 to 10% ointment as needed.
    • Children younger than 2 years of age—Use is not recommended.
  • For common warts:
    • Adults—Use the 3 to 10% ointment as needed. Use the 25 to 60% ointment one time every 3 to 5 days.
    • Children 2 years of age and older—Use the 3 to 10% ointment as needed. Use the 25 to 60% ointment one time every 3 to 5 days.
    • Children younger than 2 years of age—Use is not recommended.
• For pads dosage form:
  • For acne:
    • Adults—Use one to three times a day.
    • Children 2 years of age and older—Use one to three times a day.
    • Children younger than 2 years of age—Use is not recommended.
• For plaster dosage form:
  • For corns, calluses, common warts, or plantar warts:
    • Adults—Use once a day or once every other day.
    • Children 2 years of age and older—Use once a day or once every other day.
    • Children younger than 2 years of age—Use is not recommended.
• For shampoo dosage form:
  • For dandruff or seborrheic dermatitis of the scalp:
    • Adults—Use on the scalp one or two times a week.
    • Children 2 years of age and older—Use on the scalp one or two times a week.
    • Children younger than 2 years of age—Use is not recommended.
• For soap dosage form:
  • For acne:
    • Adults—Use as needed.
    • Children 2 years of age and older—Use as needed.
    • Children younger than 2 years of age—Use is not recommended.
• For topical solution dosage form:
  • For acne:
    • Adults—Use the 0.5 to 2% topical solution one to three times a day.
    • Children 2 years of age and older—Use the 0.5 to 2% topical solution one to three times a day.
    • Children younger than 2 years of age—Use is not recommended.
  • For common warts and plantar warts:
    • Adults—Use the 5 to 27% topical solution one or two times a day.
    • Children 2 years of age and older—Use the 5 to 27% topical solution one or two times a day.
    • Children younger than 2 years of age—Use is not recommended.
  • For corns and calluses:
    • Adults—Use the 12 to 27% topical solution one or two times a day.
    • Children 2 years of age and older—Use the 12 to 27% topical solution one or two times a day.
    • Children younger than 2 years of age—Use is not recommended.

Missed Dose

If you miss a dose of this medicine, apply 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.

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

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 immediately if any of the following side effects occur:

• Skin irritation not present before use of this medicine (moderate or severe)

• Difficult breathing
• dryness and peeling of skin
• fainting
• hives or itching
• redness of the skin
• swelling of the eyes, face, lips, or tongue
• tightness in the throat
• unusually warm skin

Get emergency help immediately if any of the following symptoms of overdose occur:

• Confusion
• diarrhea
• dizziness
• fast or deep breathing
• headache (severe or continuing)
• hearing loss
• lightheadedness
• nausea
• rapid breathing
• ringing or buzzing in the ears (continuing)
• severe drowsiness
• stomach pain
• vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Skin irritation not present before use of this medicine (mild)
• stinging

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.

Burning, redness, and peeling skin near the treated area may occur. If any of these effects persist or worsen, contact your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

People who use this drug for a long time or over large areas of skin may rarely have serious side effects caused by this drug entering the bloodstream. Children younger than 12 years and people with liver or kidney problems are more at risk. Tell your doctor right away if any of these rare but serious side effects occur: unexplained nausea/vomiting/diarrhea, rapid breathing, dizziness, hearing problems (such as ringing in the ears, hearing loss), mental/mood changes, tiredness.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using salicylic acid, tell your doctor or pharmacist if you are allergic to it; or to aspirin; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems, liver problems.

Children may be at greater risk for rare side effects from absorbing this medication into the bloodstream. (See Side Effects for more information.) This drug is similar to aspirin. Children and teenagers should not use this drug if they have chickenpox, flu, or any undiagnosed illness or if they have recently received a vaccine. In these cases, this drug may increase the risk of Reye's syndrome, a rare but serious illness.

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using salicylic acid. Salicylic acid may harm an unborn baby. If you become pregnant while using salicylic acid, talk to your doctor right away about its risk and benefits.

It is unknown if this product passes into breast milk. Consult your doctor before breast-feeding.

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

This drug should not be used with the following medication because of an increased risk of Reye's syndrome: live flu vaccine.

If you have recently received the medication listed above, or plan to receive it, tell your doctor or pharmacist before starting salicylic acid.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially: methotrexate, other aspirin/salicylate products, "water pills" (diuretics).

Tell your doctor of any over-the-counter aspirin products you may take and any cosmetic skin products you may use. If you have bothersome dry skin and/or irritation, ask your doctor or pharmacist about using moisturizing creams or lotions.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.