Brand Name

    US Brand Name

    Akurza

    Aliclen

    Avosil

    Betasal

    Compound W

    Corn Removing

    Dermarest Psoriasis

    DHS Sal

    Drytex

    Duofilm

    Duoplant

    Durasal

    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

    Salacyn

    Salex

    Salitop

    Salkera

    Sal-Plant Gel

    Salvax

    Seba-Clear

    Stri-Dex

    Thera-Sal

    Therasoft Anti-Acne

    Tinamed

    Ti-Seb

    Virasal

    Wart-Off Maximum Strength

    Zapzyt

    Canadian Brand Name

    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


    Description

    Salicylic acid topical 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.

    This medicine is available without a prescription. Some of these preparations are available only with your doctor's prescription.

    This product is available in the following dosage forms:

    • Gel/Jelly
    • Solution
    • Pad
    • Liquid
    • Spray
    • Cream
    • Ointment
    • Foam
    • Lotion
    • Soap
    • Patch, Extended Release
    • Bandage
    • Shampoo

    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

    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 children. Use of salicylic acid topical in children younger than 2 years of age is not recommended.

    Geriatric

    Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of salicylic acid topical in the elderly. However, elderly patients are more likely to have age-related blood vessel disease, which may require caution in patients receiving salicylic acid topical.

    Breastfeeding

    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.

    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. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

    Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

    • Ketorolac

    Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

    • Abciximab
    • Aceclofenac
    • Acemetacin
    • Amiloride
    • Amineptine
    • Amitriptyline
    • Amitriptylinoxide
    • Amoxapine
    • Amtolmetin Guacil
    • Anagrelide
    • Ardeparin
    • Aspirin
    • Balsalazide
    • Bemetizide
    • Bemiparin
    • Bendroflumethiazide
    • Benzthiazide
    • Betrixaban
    • Bismuth Subsalicylate
    • Bromfenac
    • Budesonide
    • Bufexamac
    • Bumetanide
    • Cangrelor
    • Celecoxib
    • Certoparin
    • Chlorothiazide
    • Chlorthalidone
    • Choline Magnesium Trisalicylate
    • Choline Salicylate
    • Cilostazol
    • Citalopram
    • Clomipramine
    • Clonixin
    • Clopamide
    • Clopidogrel
    • Cyclopenthiazide
    • Cyclosporine
    • Cyclothiazide
    • Dalteparin

    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.

    • Acebutolol
    • Acenocoumarol
    • Anisindione
    • Atenolol
    • Azilsartan
    • Azilsartan Medoxomil
    • Benazepril
    • Betaxolol
    • Bisoprolol
    • Candesartan
    • Captopril
    • Carteolol
    • Carvedilol
    • Celiprolol
    • Dicumarol
    • Enalapril
    • Enalaprilat
    • Eprosartan
    • Esmolol
    • Fosinopril
    • Irbesartan
    • Labetalol
    • Levobunolol
    • Lisinopril
    • Losartan
    • Metipranolol
    • Metoprolol
    • Moexipril
    • Nadolol
    • Nebivolol
    • Olmesartan
    • Oxprenolol
    • Penbutolol
    • Perindopril
    • Phenindione
    • Phenprocoumon
    • Pindolol
    • Probenecid
    • Propranolol
    • Quinapril

    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.

    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 or
    • Diabetes—Use with caution. 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)—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

    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.


    Precautions

    If your symptoms do not improve within a few days, or if it become worse, check with your doctor.

    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 (eg, 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.

    This medicine may cause a serious condition called salicylate toxicity. This is more likely to occur especially in children, or if you have kidney disease or liver disease. Check with your doctor right away if you have nausea, vomiting, dizziness, loss of hearing, tinnitus, lethargy hyperpnea, diarrhea, and psychic disturbances.

    Certain over-the-counter (OTC) acne products may cause rare and life-threatening allergic reactions. Check with your doctor right away if you have hives, itching, trouble breathing, swelling of the eyes, face, lips, or tongue, tightness in the throat, or feeling faint while using these products.

    Do not use an OTC acne product again if you have developed a serious allergic reaction from it.


    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 immediately if any of the following side effects occur:

    Less common or rare

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

    Incidence not known

    • 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:

    Symptoms of overdose

    • 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:

    More common

    • 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.






    CON-XXXXXXXX

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