Therasoft Anti-Acne

Generic Name: salicylic acid (Topical route)

sal-i-SIL-ik AS-id

Commonly used brand name(s):

In the U.S.

• Akurza
• Aliclen
• Avosil
• Betasal
• Compound W
• Corn Removing
• Dermarest Psoriasis
• DHS Sal
• Drytex
• Duofilm
• Duoplant
• Freezone
• Fung-O
• Gets-It Corn/Callus Remover
• Gordofilm
• Hydrisalic
• Ionil
• Ionil Plus
• Keralyt
• Keralyt Scalp
• Lupicare
• Mediplast
• Mg217 Sal-Acid
• Mosco Corn & Callus Remover
• Neutrogena
• Occlusal-HP
• Off-Ezy
• Oxy Balance
• P & S
• Palmer's Skin Success Acne Cleanser
• Propa pH
• Salac
• Sal-Acid Plaster
• Salactic Film
• Salex
• Salitop
• Salkera
• Sal-Plant Gel
• Salvax
• Seba-Clear
• Stri-Dex
• Thera-Sal
• Therasoft Anti-Acne
• Tinamed
• Ti-Seb
• Wart-Off Maximum Strength
• Zapzyt

In Canada

• Acnex
• Acnomel Acne Mask
• Clear Away Wart Removal System
• Compound W One-Step Wart Remover
• Compound W Plus
• Dr. Scholl's Clear Away One Step Plantar Wart Remover
• Dr. Scholl's Cushlin Ultra Slim Callus Removers
• Dr. Scholl's Cushlin Ultra Slim Corn Removers
• Duoforte 27
• Freezone - One Step Callus Remover Pad
• Freezone - One Step Corn Remover Pad

Available Dosage Forms:

• Soap
• Lotion
• Liquid
• Ointment
• Foam
• Gel/Jelly
• Cream
• Pad
• Shampoo
• Dressing
• Solution
• Stick

Therapeutic Class: Antiacne

Pharmacologic Class: NSAID

Chemical Class: Salicylate, Non-Aspirin

Uses For Therasoft Anti-Acne

Salicylic acid is used to treat many skin disorders, such as acne, dandruff, psoriasis, seborrheic dermatitis of the skin and scalp, calluses, corns, common warts, and plantar warts, depending on the dosage form and strength of the preparation.

Some of these preparations are available only with your doctor's prescription.

Before Using Therasoft Anti-Acne

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

Young children may be at increased risk of unwanted effects because of increased absorption of salicylic acid through the skin. Also, young children may be more likely to get skin irritation from salicylic acid. Salicylic acid should not be applied to large areas of the body, used for long periods of time, or used under occlusive dressing (air-tight covering, such as kitchen plastic wrap) in infants and children. Salicylic acid should not be used in children younger than 2 years of age.

Geriatric

Elderly people are more likely to have age-related blood vessel disease. This may increase the chance of problems during treatment with this medicine.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acenocoumarol
• Anisindione
• Ardeparin
• Certoparin
• Dalteparin
• Danaparoid
• Dicumarol
• Enoxaparin
• Nadroparin
• Parnaparin
• Phenindione
• Phenprocoumon
• Probenecid
• Reviparin
• Tamarind
• Tinzaparin
• Warfarin

Interactions with Food/Tobacco/Alcohol

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.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Blood vessel disease

• Diabetes mellitus (sugar diabetes)—Use of this medicine may cause severe redness or ulceration, especially on the hands or feet

• Inflammation, irritation, or infection of the skin—Use of this medicine may cause severe irritation if applied to inflamed, irritated, or infected area of the skin

• Influenza (flu) or
• Varicella (chicken pox)—This medicine should not be used in children and teenagers with the flu or chicken pox. There is a risk of Reye's syndrome.

• Kidney disease or
• Liver disease—Using this medicine for a long time over large areas could result in unwanted effects

Proper Use of salicylic acid

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

It is very important that you use this medicine only as directed. 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.

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 form of salicylic acid:

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

To use the gel form of salicylic acid:

• 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 health care professional.
• Apply enough gel to cover the affected areas, and rub in gently.

To use the pad form of salicylic acid:

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

To use the plaster form of salicylic acid 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 form of salicylic acid:

• 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 form of salicylic acid:

• 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 form of salicylic acid for acne:

• 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 form of salicylic acid 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 cream dosage form:
  • For corns and calluses:
    • Adults and children—Use the 2 to 10% cream as needed. Use the 25 to 60% cream one time every three to five days.
• For gel dosage form:
  • For acne:
    • Adults and children—Use the 0.5 to 5% gel one time a day.
  • For psoriasis:
    • Adults and children—Use the 5% gel one time a day.
  • For common warts:
    • Adults and children—Use the 5 to 26% gel one time a day.
• For lotion dosage form:
  • For acne:
    • Adults and children—Use the 1 to 2% lotion one to three times a day.
  • For dandruff and antiseborrhic dermatitis of the scalp:
    • Adults and children—Use the 1.8 to 2% lotion on the scalp one or two times a day.
• For ointment dosage form:
  • For acne:
    • Adults and children—Use the 3 to 6% ointment as needed.
  • For psoriasis and seborrheic dermatitis:
    • Adults and children—Use the 3 to 10% ointment as needed.
  • For common warts:
    • Adults and children—Use the 3 to 10% ointment as needed. Use the 25 to 60% ointment one time every three to five days.
• For pads dosage form:
  • For acne:
    • Adults and children—Use one to three times a day.
• For plaster dosage form:
  • For corns, calluses, common warts, or plantar warts:
    • Adults and children—Use one time a day or one time every other day.
• For shampoo dosage form:
  • For dandruff or seborrheic dermatitis of the scalp:
    • Adults and children—Use on the scalp one or two times a week.
• For soap dosage form:
  • For acne:
    • Adults and children—Use as needed.
• For topical solution dosage form:
  • For acne:
    • Adults and children—Use the 0.5 to 2% topical solution one to three times a day.
  • For common warts and plantar warts:
    • Adults and children—Use the 5 to 27% topical solution one or two times a day.
  • For corns and calluses:
    • Adults and children—Use the 12 to 27% topical solution one or two times a day.

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.

Precautions While Using Therasoft Anti-Acne

When using salicylic acid, do not use any of the following preparations on the same affected area as this medicine, unless otherwise directed by your doctor:

• Abrasive soaps or cleansers
• Alcohol-containing preparations
• Any other topical acne preparation or preparation containing a peeling agent (for example, benzoyl peroxide, resorcinol, sulfur, or tretinoin [vitamin A acid])
• Cosmetics or soaps that dry the skin
• Medicated cosmetics
• Other topical medicine for the skin

To use any of the above preparations on the same affected area as salicylic acid may cause severe irritation of the skin.

Check with your doctor right away if you have nausea, vomiting, dizziness, loss of hearing, tinnitus, lethargy hyperpnea, diarrhea, and psychic disturbances. These could be symptoms of a serious condition called salicylate toxicity, especially in children under 12 years of age and patients with kidney or liver problems.

Therasoft Anti-Acne 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 (moderate or severe)

• Dryness and peeling of skin
• flushing
• redness of skin
• unusually warm skin

• Confusion
• diarrhea
• dizziness
• fast or deep breathing
• headache (severe or continuing)
• hearing loss
• lightheadedness
• nausea
• rapid breathing
• ringing or buzzing in 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.

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