Ultravate Pack Ointment

Ammonium lactate is a combination of lactic acid and ammonium hydroxide. Ammonium lactate is a skin moisturizer.

Halobetasol is a steroid. It reduces the actions of chemicals in the body that cause inflammation.

Ammonium lactate and halobetasol topical (for the skin) is a combination medicine used to treat different skin conditions, such as eczema, rash, or allergic skin reactions.

Ammonium lactate and halobetasol topical may also be used for purposes not listed in this medication guide.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

You should not use this medicine if you are allergic to ammonium lactate or halobetasol (or other steroid medicines).

To make sure ammonium lactate and halobetasol topical is safe for you, tell your doctor if you have:

• any type of skin infection;

• diabetes; or

• a drug allergy.

FDA pregnancy category C. It is not known whether ammonium lactate and halobetasol topical will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

It is not known whether ammonium lactate and halobetasol topical passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

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

Steroid side effects may include a delay in growth with long-term use. Talk with your doctor if you think your child is not growing at a normal rate while using this medicine.

Avoid getting this medicine in your eyes.

Do not take by mouth. Topical medicine is for use only on the skin. Do not use this medicine on open wounds or on sunburned, windburned, dry, chapped, or irritated skin. If this medicine gets in your eyes, nose, mouth, rectum, or vagina, rinse with water.

Avoid using ammonium lactate and halobetasol topical to treat skin on your face, underarms, or groin area without your doctor's advice.

Avoid exposure to sunlight or tanning beds. This medicine can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
• Skin changes (pimples, stretch marks, slow healing, hair growth).
• Very bad skin irritation.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Skin irritation.
• Dry skin.
• Burning.
• Itching.
• Stinging.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Some side effects of Ultravate Pack Ointment may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.