Freezone (Topical)

Salicylic acid topical is used to treat various skin problems, including acne, dandruff, psoriasis, seborrheic dermatitis on the skin and scalp, calluses, corns, common warts, and plantar warts, depending on the form and strength of the product.

This medicine can be obtained without a prescription. Some of these products require a prescription from your doctor.

If your symptoms do not improve within a few days, or if they get worse, contact your doctor.

When using salicylic acid, do not apply any of the following products to the same affected area as this medicine, unless your doctor tells you otherwise:

• Abrasive soaps or cleansers
• Alcohol-containing products
• Any other topical acne product or product with a peeling agent (e.g., benzoyl peroxide, resorcinol, sulfur, or tretinoin [vitamin A acid])
• Cosmetics or soaps that dry the skin
• Medicated cosmetics
• Other topical skin medicines

Using any of the above products on the same affected area as salicylic acid may lead to severe skin irritation.

This medicine may cause a serious condition called salicylate toxicity. This is more likely to happen, especially in children, or if you have kidney disease or liver disease. Contact your doctor immediately if you experience nausea, vomiting, dizziness, loss of hearing, tinnitus, lethargy, hyperpnea, diarrhea, or mental disturbances.

Certain over-the-counter (OTC) acne products can cause rare and life-threatening allergic reactions. Contact your doctor immediately if you experience 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 had a serious allergic reaction to it.

In deciding to use a drug, the chances of using the medication must be weighed against the good it will do. This is a decision you and your physician will make. For this medication, the following should be considered:

Allergies

Inform your physician if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Additionally 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 significant 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. Nevertheless, elderly patients are more likely to have age-related blood vessel disease, which may require caution in patients receiving salicylic acid topical.

Breast Feeding

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

Interactions with Medications

Although certain medications should not be used together at all, in other cases two different drugs may be used together even if an interaction might occur. In these cases, your physician may want to change the dose, or other precautions may be necessary. When you are taking this drug, it is especially critical that your healthcare professional know if you are using 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 medication with any of the following drugs is not recommended. Your clinician may decide not to treat you with this medicine or change some of the other medicines you take.

• Ketorolac

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

• Abciximab
• Aceclofenac
• Acemetacin
• Amiloride
• Amineptine
• Amitriptyline
• Amitriptylinoxide
• Amoxapine
• Amtolmetin Guacil
• Anagrelide
• Ardeparin
• Aspirin
• Balsalazide
• Bemetizide
• Bemiparin
• Bendroflumethiazide
• Benzthiazide
• Betamethasone
• Betrixaban
• Bismuth Subsalicylate
• Bromfenac
• Budesonide
• Bufexamac
• Bumetanide
• Cangrelor
• Celecoxib
• Certoparin
• Chlorothiazide
• Chlorthalidone
• Choline Magnesium Trisalicylate
• Choline Salicylate
• Cilostazol
• Citalopram
• Clomipramine
• Clonixin
• Clopamide
• Clopidogrel
• Cortisone
• Cyclopenthiazide
• Cyclosporine
• Cyclothiazide
• Dalteparin
• Danaparoid
• Deflazacort
• Desipramine
• Desmopressin
• Desvenlafaxine
• Dexamethasone
• Dexibuprofen
• Dexketoprofen
• Diazoxide
• Dibenzepin
• Diclofenac
• Diflunisal
• Digoxin
• Dipyridamole
• Dipyrone
• Dothiepin
• Doxepin
• Droxicam
• Duloxetine
• Edoxaban
• Emtricitabine
• Enoxaparin
• Eplerenone
• Epoprostenol
• Eptifibatide
• Escitalopram
• Ethacrynic Acid
• Etodolac
• Etofenamate
• Etoricoxib
• Etozolin
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Feverfew
• Floctafenine
• Flufenamic Acid
• Fluocortolone
• Fluoxetine
• Flurbiprofen
• Fluvoxamine
• Furosemide
• Ginkgo
• Gossypol
• Hydrochlorothiazide
• Hydrocortisone
• Hydroflumethiazide
• Ibuprofen
• Iloprost
• Imipramine
• Indapamide
• Indomethacin
• Inotersen
• Ketoprofen
• Levomilnacipran
• Lithium
• Lofepramine
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Magnesium Salicylate
• Meadowsweet
• Meclofenamate
• Mefenamic Acid
• Melitracen
• Meloxicam
• Melphalan
• Mesalamine
• Methotrexate
• Methyclothiazide
• Methylprednisolone
• Metolazone
• Milnacipran
• Morniflumate
• Nabumetone
• Nadroparin
• Naproxen
• Nefazodone
• Nepafenac
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Nortriptyline
• Olsalazine
• Opipramol
• Oxaprozin
• Oxyphenbutazone
• Paramethasone
• Parecoxib
• Parnaparin
• Paroxetine
• Pemetrexed
• Pentosan Polysulfate Sodium
• Pentoxifylline
• Phenylbutazone
• Phenyl Salicylate
• Piketoprofen
• Piretanide
• Piroxicam
• Polythiazide
• Potassium Citrate
• Prasugrel
• Prednisolone
• Prednisone
• Proglumetacin
• Propyphenazone
• Proquazone
• Protriptyline
• Quinethazone
• Reviparin
• Rofecoxib
• Salicylamide
• Salicylic Acid
• Salsalate
• Selexipag
• Sertraline
• Sibutramine
• Sodium Salicylate
• Spironolactone
• Sulfasalazine
• Sulfinpyrazone
• Sulindac
• Tacrolimus
• Tenofovir Alafenamide
• Tenofovir Disoproxil Fumarate
• Tenoxicam
• Tianeptine
• Tiaprofenic Acid
• Ticagrelor
• Ticlopidine
• Tinzaparin
• Tirofiban
• Tolfenamic Acid
• Tolmetin
• Torsemide
• Trazodone
• Treprostinil
• Triamterene
• Trichlormethiazide
• Trimipramine
• Trolamine Salicylate
• Valdecoxib
• Venlafaxine
• Vilazodone
• Vorapaxar
• Vortioxetine
• Xipamide

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 therapy for you. If both medications are prescribed together, your physician may change the dose or how often you use one or both of the drugs.

• 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
• Ramipril
• Sotalol
• Spirapril
• Tamarind
• Telmisartan
• Timolol
• Trandolapril
• Valsartan
• 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 medications 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 issues may affect the use of this medication. Make sure you tell your clinician if you have any other medical problems, especially:

• Blood vessel disease or
• Diabetes—Use with caution. May cause serious redness or ulceration, especially on the hands or feet.

• Inflammation, irritation, or infection of the skin—Use of this medicine may cause serious 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 drug for a long time over large areas could result in unwanted effects.

Along with its necessary effects, this medicine can cause some unwanted effects. Not all of these side effects may happen, but if they do, they may require medical attention.

Check with your doctor right away if you experience any of the following side effects:

Less common or rare

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

Incidence not known

• Difficulty 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 right away if you notice any of the following overdose symptoms:

Symptoms of overdose

• Confusion
• Diarrhea
• Dizziness
• Fast or deep breathing
• Severe or ongoing headache
• Hearing loss
• Lightheadedness
• Nausea
• Rapid breathing
• Ringing or buzzing in the ears (ongoing)
• Severe drowsiness
• Stomach pain
• Vomiting

Some side effects may happen that usually do not require medical attention. These side effects may go away as your body gets used to the medicine. Your healthcare professional may also have ways to help prevent or lessen some of these side effects. Talk to your healthcare professional if any of the following side effects continue, bother you, or if you have questions about them:

More common

• Skin irritation not present before using 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.

In the U.S.

• 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

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:

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

Therapeutic Class: Keratolytic

Pharmacologic Class: NSAID

Chemical Class: Salicylate, Non-Aspirin

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.

• Does duct tape really remove warts?