Betamethasone 0.1% w/w (as valerate) cream.

Do not use betamethasone longer than you have been told to by your doctor. Use care when using on a large part of the skin. Talk with your doctor.

Do not use to treat diaper rash or redness. Avoid applying betamethasone cream, gel, ointment, lotion, foam, or spray to the diaper area.

If you are breastfeeding, do not apply betamethasone cream, gel, ointment, lotion, foam, or spray to the nipple or the area around it.

You should not use betamethasone if you are allergic to it.

To make sure betamethasone is safe for you, tell your doctor if you have ever had:

• skin irritation after using steroid medicine;

• thinning of the skin where you will apply betamethasone;

• cataracts or glaucoma;

• diabetes;

• liver disease;

• adrenal gland problems; or

• any type of skin infection.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant.

It may not be safe to breastfeed a baby while you are using this medicine. Ask your doctor about any risks. If you apply betamethasone to your chest, avoid areas that may come into contact with the baby's mouth.

Do not use betamethasone on a child without a doctor's advice. Children can absorb larger amounts of this medicine through the skin and may be more likely to have side effects.

Use betamethasone cream, gel, ointment, lotion, foam, or spray exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Do not take by mouth. Topical medicine is for use only on the skin. Do not use on open wounds or on sunburned, windburned, dry, or irritated skin. Rinse with water if this medicine gets in your eyes or mouth.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Wash your hands before and after using this medicine, unless you are using the medicine to treat the skin on your hands.

Apply a small amount to the affected area and rub it gently into the skin. Do not apply betamethasone cream, gel, ointment, lotion, foam, or spray over a large area of skin.

Do not cover the treated skin area unless your doctor tells you to. Covering treated areas can increase the amount of medicine absorbed through your skin and may cause harmful effects.

Use betamethasone regularly to get the most benefit. Stop using the medicine once your symptoms clear up.

Call your doctor if your skin condition does not improve after 2 weeks, or if it gets worse.

Each gram of Betamethasone Valerate Cream USP, 0.1% contains: 1.2 mg betamethasone valerate USP (equivalent to 1.0 mg betamethasone) with mineral oil, white petrolatum, ceteth-20, cetyl alcohol, stearyl alcohol, propylene glycol, phosphoric acid, sodium phosphate monobasic, sodium hydroxide, purified water and 4-chloro-m-cresol as a preservative.

Get emergency medical help if you have signs of an allergic reaction to betamethasone: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using betamethasone and call your doctor at once if you have:

• severe skin irritation where the medicine was applied; or

• signs of skin infection (swelling, redness, warmth, oozing).

Your skin can absorb topical steroid medicine, which may cause steroid side effects throughout the body. Stop using betamethasone and call your doctor if you have:

• blurred vision, tunnel vision, eye pain, or seeing halos around lights;

• slow wound healing, thinning skin, increased body hair;

• increased thirst or urination, dry mouth, fruity breath odor;

• weight gain, puffiness in your face; or

• muscle weakness, tired feeling, depression, anxiety, feeling irritable.

Steroids can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using this medicine.

Common betamethasone side effects may include:

• itching, redness, burning, stinging, or blistering of treated skin;

• skin bruising or shiny appearance; or

• folliculitis (redness or crusting around your hair follicles).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.