Keratol HC (Topical application)

Hydrocortisone topical is used to help reduce redness, itching, swelling, or other discomfort from skin conditions. This medicine is a corticosteroid (cortisone-like medicine or steroid).

This medicine can be bought over-the-counter (OTC) or with a prescription from your doctor.

It is very important for your doctor to check your or your child's progress 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 a few days, or if they get worse, contact your doctor.

Using too much of this medicine or using it for a long time may increase your risk of adrenal gland problems. This risk is higher for children and patients who use large amounts for a long time. Talk to your doctor immediately 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.

Stop using this medicine and contact your doctor right away if you or your child develop a skin rash, burning, stinging, swelling, or irritation on the skin.

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

In deciding to use a medicine, you need to think about the risks and benefits. This is a choice you will make 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 health care professional about any other allergies, like to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Studies have not shown specific problems that would limit the use of hydrocortisone topical in children. However, due to the potential risks, it should be used carefully. Children may absorb significant amounts through their skin, which can lead to serious side effects. If your child is using this medicine, follow your doctor's instructions closely.

Geriatric

There is no information available about the effects of hydrocortisone topical in older patients.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together, while others can be used together even if there might be an interaction. In these cases, your doctor may change the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used around meal times or with specific types of food due to potential interactions. Using alcohol or tobacco with some medicines may also cause interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect the use of this medicine. Be sure to tell 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. May worsen these conditions.

• Infection of the skin at or near where you apply the medicine or
• Large sores, broken skin, or severe skin injury at the application site—The risk of side effects may be higher.

Along with its needed effects, this medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do, 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
• irritation
• itching, scaling, severe redness, soreness, or swelling of the skin
• redness and scaling around the mouth
• thinning of the skin with easy bruising, especially when used on the face or where the skin folds together (e.g. between the fingers)
• thinning, weakness, or wasting away of the skin

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
• 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
• increased hair growth on the forehead, back, arms, and legs
• lightening of normal skin color
• lightening of treated areas of dark skin
• reddish purple lines on the arms, face, legs, trunk, or groin
• softening of the 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.

• Ala-Cort
• Ala-Scalp HP
• Anusol HC
• Aquanil HC
• Beta HC
• Caldecort
• Cetacort
• Cortaid
• Corticaine
• Corticool Maximum Strength
• Cortizone-10
• Cortizone-5
• Cotacort
• Delacort
• Dermarest
• Dermasorb HC Complete Kit
• Dermtex-HC
• Gly-Cort
• Hydrozone Plus
• Hytone
• Instacort-10
• Ivy Soothe
• IvyStat
• Keratol HC
• Kericort 10
• Lacticare-HC
• Locoid
• Locoid Lipocream
• Medi-Cortisone Maximum Strength
• Microcort
• Mycin Scalp
• Neutrogena T/Scalp
• NuCort
• Nupercainal HC
• Nutracort
• Pandel
• Pediaderm HC Kit
• Preparation H Hydrocortisone
• Proctocream-HC
• Recort Plus
• Sarnol-HC Maximum Strength
• Scalacort
• Scalpcort
• Summer's Eve Specialcare
• Texacort
• Therasoft Anti-Itch & Dermatitis
• U-Cort
• Westcort

In Canada

• Barriere-Hc
• Cortate
• Cort-Eze
• Cortoderm Mild Ointment
• Cortoderm Regular Ointment
• Emo-Cort
• Emo-Cort Scalp Solution
• Hydrocortisone Cream
• Novo-Hydrocort
• Novo-Hydrocort Cream
• Prevex Hc
• Sarna Hc

Available Dosage Forms:

• Lotion
• Cream
• Solution
• Spray
• Gel/Jelly
• Ointment
• Foam
• Liquid

Therapeutic Class: Corticosteroid, Weak

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. 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.

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.

To use:

• 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.
• With the lotion, shake it well before using.
• Do not bandage or otherwise wrap the skin being treated unless directed to do so by your doctor.
• If the medicine is applied to the diaper area of an infant, do not use tight-fitting diapers or plastic pants unless directed to do so by your doctor.
• If your doctor ordered an occlusive dressing or airtight covering to be applied over the medicine, make sure you know how to apply it. Occlusive dressings increase the amount of medicine absorbed through your skin, so use them only as directed. If you have any questions about this, check with 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 redness, itching, and swelling of the skin:For topical dosage form (cream): Adults—Apply to the affected area of the skin two or three times per day. Children—Apply to the affected area of the skin two or three times per day. For topical dosage form (lotion): Adults—Apply to the affected area of the skin two to four times per day. Children—Apply to the affected area of the skin two to four times per day. For topical dosage form (ointment): Adults—Apply to the affected area of the skin three or four times per day. Children—Apply to the affected area of the skin three or four times per day. For topical dosage form (solution): Adults—Apply to the affected area of the skin three or four times per day. Children—Apply to the affected area of the skin three or four times per 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.

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