Dermasorb AF Complete Kit (Topical)

Clioquinol and hydrocortisone is a combined anti-infective and cortisone-like medicine. Clioquinol and hydrocortisone topical preparation is used to treat skin infections and to help relieve redness, itching, and discomfort from various skin issues.

This medicine is available only with your doctor's prescription.

It is very important that your doctor checks the progress of you or your child during regular visits for any unwanted effects that may be caused by this medicine.

If your or your child's symptoms do not improve within 1 to 2 weeks, or if they get worse, check with your doctor.

This medicine may stain clothing, skin, hair, and nails yellow. Avoid getting this medicine on your clothing. Bleaching may not remove the stain.

Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems. The risk is greater for children and patients who use large amounts for a long time. Talk to your doctor right away if you or your child have more than one of these symptoms while using this medicine: blurred vision, dizziness or fainting, a fast, irregular, or pounding heartbeat, increased thirst or urination, irritability, or unusual tiredness or weakness.

This medicine may make your skin more sensitive to sunlight. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds.

Avoid using tight-fitting diapers or plastic pants on a child if this medicine is being used on the child's diaper area. Plastic pants and tight-fitting diapers may increase the chance of absorption of the medicine through the skin and the chance of side effects.

Do not use cosmetics or other skin care products on the treated skin areas.

In deciding to use a medicine, you need to consider the risks of taking it against the benefits it may provide. This decision should be made together with your doctor. For this medicine, consider the following:

Allergies

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

Pediatric

Studies so far have not shown any specific problems that would limit the use of clioquinol and hydrocortisone topical cream in children 2 years of age and older. However, because this medicine can be toxic, it should be used carefully. Children can absorb large amounts through their skin, which may lead to serious side effects. If your child is using this medicine, follow your doctor's instructions closely. The use of clioquinol and hydrocortisone topical cream is not recommended for infants or children under 2 years of age.

Geriatric

There is no information available on how age affects the use of clioquinol and hydrocortisone topical cream in older patients.

Breast Feeding

There are no adequate studies on the risk to infants when this medication is used during breastfeeding. Weigh the potential benefits against the risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together. In other cases, two different medicines may be used together, but your doctor may need to adjust the dose or take other precautions. When you are taking this medicine, it is very important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions are significant and 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.

• Desmopressin
• Rotavirus Vaccine, Live

Using this medicine with any of the following medicines is usually not recommended, but may be necessary 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.

• Abametapir
• Aceclofenac
• Acemetacin
• Aldesleukin
• Amtolmetin Guacil
• Aspirin
• Atazanavir
• Balofloxacin
• Bemiparin
• Besifloxacin
• Bromfenac
• Bufexamac
• Bupropion
• Celecoxib
• Choline Salicylate
• Ciprofloxacin
• Clonixin
• Cobicistat
• Conivaptan
• Darunavir
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Diflunisal
• Dipyrone
• Droxicam
• Enoxacin
• Etodolac
• Etofenamate
• Etoricoxib
• Fedratinib
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Fexinidazole
• Fleroxacin
• Floctafenine
• Flufenamic Acid
• Flumequine
• Flurbiprofen
• Fosnetupitant
• Gatifloxacin
• Gemifloxacin
• Ibuprofen
• Indomethacin
• Itraconazole
• Ketoprofen
• Ketorolac
• Lenacapavir
• Levofloxacin
• Lomefloxacin
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Lutetium Lu 177 Dotatate
• Macimorelin
• Mavacamten
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Morniflumate
• Moxifloxacin
• Nabumetone
• Nadifloxacin
• Nadroparin
• Naproxen
• Nepafenac
• Netupitant
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Norfloxacin
• Ofloxacin
• Omaveloxolone
• Oxaprozin
• Oxyphenbutazone
• Parecoxib
• Pazufloxacin
• Pefloxacin
• Phenobarbital
• Phenylbutazone
• Piketoprofen
• Piroxicam
• Pranoprofen
• Primidone
• Proglumetacin
• Propyphenazone
• Proquazone
• Prulifloxacin
• Rofecoxib
• Rufloxacin
• Salicylic Acid
• Salsalate
• Sargramostim
• Sodium Salicylate
• Somatrogon-ghla
• Sparfloxacin
• Sulindac
• Tenoxicam
• Tiaprofenic Acid
• Tolfenamic Acid
• Tolmetin
• Tosufloxacin
• Valdecoxib

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both 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.

• Alcuronium
• Atracurium
• Auranofin
• Colestipol
• Gallamine
• Hexafluorenium
• Licorice
• Metocurine
• Rifapentine
• Saiboku-To

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used around the time of eating food or specific types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also cause interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical problems may affect the use of this medicine. Make sure to inform your doctor if you have any other medical issues, especially:

• Cushing's syndrome (adrenal gland disorder) or
• Diabetes or
• Hyperglycemia (high blood sugar) or
• Intracranial hypertension (increased pressure in the head)—Use with caution. This may worsen these conditions.

• Infections (e.g., herpes simplex, vaccinia, varicella)—Should not be used in patients with these infections.

• Infection of the skin at or near the application site or
• Large sores, broken skin, or severe skin injury at the application site—This may increase the chance of 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:

Incidence not known

• Blistering, burning, crusting, dryness, or flaking of the skin
• Burning and itching of the skin with pinhead-sized red blisters
• Burning, itching, and pain in hairy areas, or pus at the root of the hair
• Darkening of the skin
• Diarrhea
• Dizziness
• Dryness
• Fainting
• Fast heartbeat
• Fever
• Hives, itching, or rash
• Hoarseness
• Irritation
• Itching, scaling, severe redness, soreness, or swelling of the skin
• Joint pain, stiffness, or swelling
• Loss of appetite
• Mental depression
• Nausea
• Reddish purple lines on the arms, face, legs, trunk, or groin
• Redness and scaling around the mouth
• Softening of the skin
• Swelling of the eyelids, face, lips, hands, or feet
• Thinning of the skin with easy bruising, especially when used on the face or where the skin folds together (e.g., between the fingers)
• Tightness in the chest
• Troubled breathing or swallowing
• Unusual tiredness or weakness
• 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:

Incidence not known

• Acne or pimples
• Increased hair growth on the forehead, back, arms, and legs
• Lightening of normal skin color
• Lightening of the treated areas of dark skin

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.

• Dermasorb AF Complete Kit

In Canada

• Vioform Hydrocortisone
• Vioform Hydrocortisone Mild

Available Dosage Forms:

• Cream

Therapeutic Class: Anti-Infective/Anti-Inflammatory Combination

Pharmacologic Class: Adrenal Glucocorticoid

It is very important that you 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 your doctor ordered. To do so may cause unwanted side effects or skin irritation.

This medicine is for use on the skin only. Do not get it in your eyes, nose, mouth, or vagina. Do not use it on skin areas that have cuts, scrapes, or burns. If it does get on these areas, rinse it off right away with water.

To help clear up your skin problem completely, it is very important that you keep using this medicine for the full time of treatment. Do not miss any doses.

This medicine should only be used for skin conditions that your doctor is treating. Check with your doctor before using it for other conditions, especially if you think that a skin infection may be present. This medicine should not be used to treat certain kinds of skin infections or conditions, such as severe burns.

Do not use this medicine on the face, groin, or underarms, or have skin thinning unless directed to do so by your doctor.

To use the cream, lotion, or ointment:

• Wash your hands with soap and water before and after using this medicine.
• Apply a thin layer of this medicine to the affected area of the skin. Rub it in gently.
• Do not bandage or otherwise wrap the area of the skin being treated unless directed to do so by your doctor.

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 forms (cream, lotion, or ointment): For bacterial and fungus infections: Adults and children 2 years of age or older—Apply to the affected area of the skin two to four times a day. Children up to 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.