Ultravate Cream (Halobetasol Propionate)

Do’s

• If available, read the leaflet provided by your pharmacist before starting to use Ultravate Cream. If you have any questions, ask your healthcare provider.
• Use Ultravate Cream only on the skin.
• Apply a thin layer of the cream to the affected area(s) as directed by your healthcare provider. Gently rub in the medication. The usual frequency of application is one to two times per day.
• After applying the cream, wash your hands unless you are using Ultravate Cream to treat your hands.
• Use Ultravate Cream only for the condition it was prescribed for.
• If your condition does not show signs of improvement or worsens, inform your healthcare provider.

Don’ts

• Do not apply the cream to the face, groin, or underarms unless specifically directed by your healthcare provider.
• Do not cover, bandage, or wrap the treated area after applying Ultravate Cream, unless directed by your healthcare provider.
• Take care to avoid getting Ultravate Cream in your eyes, nose, or mouth. If accidental contact occurs, rinse thoroughly with water.
• Do not apply the cream more than directed, use it more often, or use it for a longer duration than prescribed by your healthcare provider.

• Skin irritation, burning or stinging sensation, dryness, itching, redness, or changes in skin color
• Adrenal suppression
• Thinning of the skin
• Changes in body fat distribution, such as increased fat in the face, neck, back, and waist
• Acne or facial hair growth
• Menstrual problems
• Sexual side effects, such as impotence or loss of interest in sex

This is not an exhaustive list, and other side effects may occur. If you experience any unusual or severe side effects while using Ultravate Cream, contact your healthcare provider for medical advice.

Ultravate Cream may cause suppression of the hypothalamic-pituitary-adrenal (HPA) axis, which can affect the body's response to stress. Periodic evaluation for HPA axis suppression may be required during treatment with Ultravate Cream.

Avoid using multiple corticosteroid-containing products simultaneously, as this may increase the total systemic exposure to corticosteroids.

Topical corticosteroids, including Ultravate Cream, may cause local adverse reactions. These reactions may be more likely to occur with occlusive use, prolonged use, or use of higher potency corticosteroids. Follow the instructions provided by your healthcare provider.

Topically applied Ultravate Cream can be absorbed in sufficient amounts to produce systemic effects. This should be taken into consideration, especially when using the cream over large areas or for an extended period of time.

Pediatric patients may be more susceptible to systemic toxicity from equivalent doses of Ultravate Cream due to their larger skin surface to body mass ratios. If irritation develops, the cream should be discontinued, and appropriate therapy should be initiated.

Ultravate Cream is contraindicated in patients with a history of hypersensitivity to any of its components.

Consult with your healthcare provider for personalized advice and discuss any specific concerns or conditions you may have before using Ultravate Cream.

Product Insert {https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019968s011lbl.pdf}