Ammonium lactate and halobetasol topical kit

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.

Apply the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up the missed dose.

An overdose of ammonium lactate and halobetasol topical is not expected to be dangerous. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medication.

An overdose of ammonium lactate and halobetasol topical is not expected to produce life threatening symptoms. However, long term use of high steroid doses can lead to symptoms such as thinning skin, easy bruising, changes in the shape or location of body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

It is not likely that other drugs you take orally or inject will have an effect on topically applied ammonium lactate and halobetasol topical. But many drugs can interact with each other. Tell each of your health care providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.

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 ammonium lactate / halobetasol topical may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.