Clobetasol Propionate Aerosol label

Clobetasol Propionate Aerosol

Clobetasol Propionate Aerosol Recall

Get an alert when a recall is issued.

Side Effects & Adverse Reactions

FLAMMABLE. AVOID FIRE, FLAME OR SMOKING DURING AND IMMEDIATELY FOLLOWING APPLICATION. Keep out of reach of children. Contents under pressure. Do not puncture or incinerate container. Do not expose to heat or store at temperatures above 120
oF (49
oC).

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses


Clobetasol propionate foam, 0.05% is a super-potent topical corticosteroid indicated for short-term topical treatment of the inflammatory and pruritic manifestations of moderate to severe corticosteroid responsive dermatoses of the scalp, and for short-term topical treatment of mild to moderate plaque-type psoriasis of non-scalp regions excluding the face and intertriginous areas.

Treatment beyond 2 consecutive weeks is not recommended and the total dosage should not exceed 50 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. In a controlled pharmacokinetic study, some subjects experienced reversible suppression of the adrenals following 14 days of clobetasol propionate foam, 0.05% therapy (See ADVERSE REACTIONS).

Use in children under 12 years of age is not recommended.

History

There is currently no drug history available for this drug.

Other Information


Clobetasol propionate foam, 0.05% contains clobetasol propionate, USP, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity.

Clobelasol propionate is is pregna-1,4-diene-3,20-dione, 21-chloro-9-fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)-, (11β,16β)-, with the empirical formula C
25H
3
2CIF0
5, a molecular weight of 466.97. The following is the chemical structure:

Clobetasol_propionate_structural_formula_01

Clobetasol propionate is a white or almost white, odorless, crystalline powder and is insoluble in water.

Clobetasol propionate foam, 0.05% contains 0.5 mg clobetasol propionate, USP, per gram in a thermolabile hydroethanolic foam vehicle consisting of cetyl alcohol, citric acid, ethanol (60%), polysorbate 60, potassium citrate, propylene glycol, purified water, and stearyl alcohol pressurized with a hydrocarbon (propane/butane) propellant.

Clobetasol Propionate Aerosol Manufacturers

  • Dpt Laboratories, Ltd.
    Clobetasol Propionate Aerosol | Dpt Laboratories, Ltd.
    No Recall

    Clobetasol Propionate Aerosol | Dpt Laboratories, Ltd.

    Clobetasol Propionate Aerosol | Dpt Laboratories, Ltd.

    Note: For proper dispensing of foam, hold the can upside down and depress the actuator.

    Clobetasol propionate foam, 0.05% should be applied to the affected area twice daily, once in the morning and once at night. Invert the can and dispense a small amount of clobetasol propionate foam, 0.05% (up to a maximum of a golf-ball-size dollop or one and a half capfuls) into the cap of the can, onto a saucer or other cool surface, or to the lesion, taking care to avoid contact with the eyes. Dispensing directly onto hands is not recommended (unless the hands are the affected area), as the foam will begin to melt immediately upon contact with warm skin. When applying clobetasol propionate foam, 0.05% to a hair-bearing area, move the hair away from the affected area so that the foam can be applied to each affected area. Pick up small amounts with fingertips and gently massage into affected area until the foam disappears. Repeat until entire affected area is treated.

    Apply the smallest amount possible that sufficiently covers the affected area(s). No more than one and a half capfuls of foam should be used at each application. Do not apply to face or intertriginous areas.

    Clobetasol propionate foam, 0.05% is a super-high-potency topical corticosteroid; therefore, treatment should be limited to 2 consecutive weeks and amounts greater than 50 g/week should not be used. Use in pediatric patients under 12 years of age is not recommended.

    Unless directed by a physician, clobetasol propionate foam, 0.05% should not be used with occlusive dressings.

  • Perrigo New York Inc
    Clobetasol Propionate Aerosol | Perrigo New York Inc
    No Recall

    Clobetasol Propionate Aerosol | Perrigo New York Inc

    Clobetasol Propionate Aerosol | Perrigo New York Inc

    Note: For proper dispensing of foam, hold the can upside down and depress the actuator.

    Clobetasol propionate foam, 0.05% should be applied to the affected area twice daily, once in the morning and once at night. Invert the can and dispense a small amount of clobetasol propionate foam, 0.05% (up to a maximum of a golf-ball-size dollop or one and a half capfuls) into the cap of the can, onto a saucer or other cool surface, or to the lesion, taking care to avoid contact with the eyes. Dispensing directly onto hands is not recommended (unless the hands are the affected area), as the foam will begin to melt immediately upon contact with warm skin. When applying clobetasol propionate foam, 0.05% to a hair-bearing area, move the hair away from the affected area so that the foam can be applied to each affected area. Pick up small amounts with fingertips and gently massage into affected area until the foam disappears. Repeat until entire affected area is treated.

    Apply the smallest amount possible that sufficiently covers the affected area(s). No more than one and a half capfuls of foam should be used at each application. Do not apply to face or intertriginous areas.

    Clobetasol propionate foam, 0.05% is a super-high-potency topical corticosteroid; therefore, treatment should be limited to 2 consecutive weeks and amounts greater than 50 g/week should not be used. Use in pediatric patients under 12 years of age is not recommended.

    Unless directed by a physician, clobetasol propionate foam, 0.05% should not be used with occlusive dressings.

    Instructions for applying clobetasol propionate foam, 0.05%

    Apply clobetasol propionate foam, 0.05% twice a day, once in the morning and once at night. Apply only enough to cover the affected areas. Clobetasol propionate foam, 0.05% should not be applied to the groin, armpits, or other skin fold areas.

    To use clobetasol propionate foam, 0.05%:

    Before applying clobetasol propionate foam, 0.05% for the first time, break the tiny plastic piece at the base of the can’s rim by gently pushing back (away from the piece) on the nozzle.

    Turn the can upside down.

    Push the button to squirt a small amount of clobetasol propionate foam, 0.05% into the cap of the can, onto a saucer or other cool surface, or your affected skin area. This amount should be no more than 1 ½ capfuls, about the size of a golf ball.

     Do not squirt clobetasol propionate foam, 0.05% directly onto hands (unless your hands are the affected areas) because the foam will begin to melt right away on contact with your warm skin.

    If your fingers are warm, rinse them in cold water first. (Be sure to dry them thoroughly before handling the foam.

    If the can seems warm or the foam seems runny, run the can under cold water.

    Using your fingertips, gently massage clobetasol propionate foam, 0.05% into the affected areas until the foam disapppears.

    If you are treating areas with hair such as the scalp, move any hair away so that the foam can be applied directly to the affected areas.

    Repeat the process until the affected areas are treated.

     

    Keep the foam away from your eyes, as it will sting and may cause eye problems if there is frequent contact with your eyes. If the foam gets in your eyes, rinse them well with cold water right away. If the stinging continues, contact your doctor right away.

    Wash your hands after applying clobetasol propionate foam, 0.05%. Throw away any of the unused medicine that you squirted out of the can.

  • Physicians Total Care, Inc.
    Clobetasol Propionate Aerosol | Physicians Total Care, Inc.
    No Recall

    Clobetasol Propionate Aerosol | Physicians Total Care, Inc.

    Clobetasol Propionate Aerosol | Physicians Total Care, Inc.

    Note: For proper dispensing of foam, hold the can upside down and depress the actuator.

    Clobetasol propionate foam, 0.05% should be applied to the affected area twice daily, once in the morning and once at night. Invert the can and dispense a small amount of clobetasol propionate foam, 0.05% (up to a maximum of a golf-ball-size dollop or one and a half capfuls) into the cap of the can, onto a saucer or other cool surface, or to the lesion, taking care to avoid contact with the eyes. Dispensing directly onto hands is not recommended (unless the hands are the affected area), as the foam will begin to melt immediately upon contact with warm skin. When applying clobetasol propionate foam, 0.05% to a hair-bearing area, move the hair away from the affected area so that the foam can be applied to each affected area. Pick up small amounts with fingertips and gently massage into affected area until the foam disappears. Repeat until entire affected area is treated.

    Apply the smallest amount possible that sufficiently covers the affected area(s). No more than one and a half capfuls of foam should be used at each application. Do not apply to face or intertriginous areas.

    Clobetasol propionate foam, 0.05% is a super-high-potency topical corticosteroid; therefore, treatment should be limited to 2 consecutive weeks and amounts greater than 50 g/week should not be used. Use in pediatric patients under 12 years of age is not recommended.

    Unless directed by a physician, clobetasol propionate foam, 0.05% should not be used with occlusive dressings.

    Instructions for applying clobetasol propionate foam, 0.05% Apply clobetasol propionate foam, 0.05% twice a day, once in the morning and once at night. Apply only enough to cover the affected areas. Clobetasol propionate foam, 0.05% should not be applied to the groin, or other skin fold areas.

    To use clobetasol propionate foam, 0.05%:

    Before applying clobestasol propionate foam, 0.05% for the first time, break the tiny plastic piece at the base of the can's rim by gently pushing back (away from the piece) on the nozzle.

    Turn the can upside down.


    Push the button to squirt a small amount of clobetasol propionate foam, 0.05% into the cap of the can, onto a saucer or other cool surface, or your affected skin area. This amount should be no more than 1 1/2 capfuls, about the size of a golf ball.

    Do not squirt clobetasol propionate foam, 0.05% directly onto your hands (unless your hands are the affected areas), because the foam will begin to melt right away on contact with your warm skin.

    If your fingers are warm, rinse them in cold water first. (Be sure to dry them thoroughly before handling the foam.)

    If the can seems warm or the foam seems runny, run the can under cold water.

    Using your fingertips, gently massage clobetasol propionate foam, 0.05% into the affected areas until the foam disappears.

    If you are treating areas with hair such as the scalp, move any hair away so that the foam can be applied directly to the affected areas.

    Repeat the process until the affected areas are treated.

    Keep the foam away from your eyes, as it will sting and may cause eye problems if there is frequent contact with your eyes. If the foam gets your eyes, rinse them well with cold water right away. If the stinging continues, contact your doctor right away.

    Wash your hands after apply clobetasol propionate foam, 0.05%. Throw away any of the unused medicine that you squirted out of the can.

  • Prasco Laboratories
    Clobetasol Propionate Aerosol | Prasco Laboratories
    No Recall

    Clobetasol Propionate Aerosol | Prasco Laboratories

    Clobetasol Propionate Aerosol | Prasco Laboratories

    Note: For proper dispensing of foam, hold the can upside down and depress the actuator.

    Clobetasol propionate foam, 0.05% should be applied to the affected area twice daily, once in the morning and once at night. Invert the can and dispense a small amount of clobetasol propionate foam, 0.05% (up to a maximum of a golf-ball-size dollop or one and a half capfuls) into the cap of the can, onto a saucer or other cool surface, or to the lesion, taking care to avoid contact with the eyes. Dispensing directly onto hands is not recommended (unless the hands are the affected area), as the foam will begin to melt immediately upon contact with warm skin. When applying clobetasol propionate foam, 0.05% to a hair-bearing area, move the hair away from the affected area so that the foam can be applied to each affected area. Pick up small amounts with fingertips and gently massage into affected area until the foam disappears. Repeat until entire affected area is treated.

    Apply the smallest amount possible that sufficiently covers the affected area(s). No more than one and a half capfuls of foam should be used at each application. Do not apply to face or intertriginous areas.

    Clobetasol propionate foam, 0.05% is a super-high-potency topical corticosteroid; therefore, treatment should be limited to 2 consecutive weeks and amounts greater than 50 g/week should not be used. Use in pediatric patients under 12 years of age is not recommended.

    Unless directed by a physician, clobetasol propionate foam, 0.05% should not be used with occlusive dressings.

    Instructions for applying clobetasol propionate foam, 0.05%

    Apply clobetasol propionate foam, 0.05% twice a day, once in the morning and once at night. Apply only enough to cover the affected areas. Clobetasol propionate foam, 0.05% should not be applied to the groin, or other skin fold areas.

    To use clobetasol propionate foam, 0.05%:

    Before applying clobestasol propionate foam, 0.05% for the first time, break the tiny plastic piece at the base of the can's rim by gently pushing back (away from the piece) on the nozzle.

    Turn the can upside down.

    Push the button to squirt a small amount of clobetasol propionate foam, 0.05% into the cap of the can, onto a saucer or other cool surface, or your affected skin area. This amount should be no more than 1 1/2 capfuls, about the size of a golf ball.

    Do not squirt clobetasol propionate foam, 0.05% directly onto your hands (unless your hands are the affected areas), because the foam will begin to melt right away on contact with your warm skin.

    If your fingers are warm, rinse them in cold water first. (Be sure to dry them thoroughly before handling the foam.)

    If the can seems warm or the foam seems runny, run the can under cold water.

    Using your fingertips, gently massage clobetasol propionate foam, 0.05% into the affected areas until the foam disappears.

    If you are treating areas with hair such as the scalp, move any hair away so that the foam can be applied directly to the affected areas.

    Repeat the process until the affected areas are treated.

    Keep the foam away from your eyes, as it will sting and may cause eye problems if there is frequent contact with your eyes. If the foam gets your eyes, rinse them well with cold water right away. If the stinging continues, contact your doctor right away.

    Wash your hands after apply clobetasol propionate foam, 0.05%. Throw away any of the unused medicine that you squirted out of the can.

  • Renaissance Pharma, Inc.
    Clobetasol Propionate Aerosol | Renaissance Pharma, Inc.
    No Recall

    Clobetasol Propionate Aerosol | Renaissance Pharma, Inc.

    Clobetasol Propionate Aerosol | Renaissance Pharma, Inc.

    Note: For proper dispensing of foam, hold the can upside down and depress the actuator.

    Clobetasol propionate foam, 0.05% should be applied to the affected area twice daily, once in the morning and once at night. Invert the can and dispense a small amount of clobetasol propionate foam, 0.05% (up to a maximum of a golf-ball-size dollop or one and a half capfuls) into the cap of the can, onto a saucer or other cool surface, or to the lesion, taking care to avoid contact with the eyes. Dispensing directly onto hands is not recommended (unless the hands are the affected area), as the foam will begin to melt immediately upon contact with warm skin. When applying clobetasol propionate foam, 0.05% to a hair-bearing area, move the hair away from the affected area so that the foam can be applied to each affected area. Pick up small amounts with fingertips and gently massage into affected area until the foam disappears. Repeat until entire affected area is treated.

    Apply the smallest amount possible that sufficiently covers the affected area(s). No more than one and a half capfuls of foam should be used at each application. Do not apply to face or intertriginous areas.

    Clobetasol propionate foam, 0.05% is a super-high-potency topical corticosteroid; therefore, treatment should be limited to 2 consecutive weeks and amounts greater than 50 g/week should not be used. Use in pediatric patients under 12 years of age is not recommended.

    Unless directed by a physician, clobetasol propionate foam, 0.05% should not be used with occlusive dressings.

    Instructions for applying clobetasol propionate foam, 0.05%  

    Apply clobetasol propionate foam, 0.05% twice a day, once in the morning and once at night. Apply only enough to cover the affected areas. Clobetasol propionate foam, 0.05% should not be applied to the groin, or other skin fold areas.

    To use clobetasol propionate foam, 0.05%:

       

    Before applying clobestasol propionate foam, 0.05% for the first time, break the tiny plastic piece at the base of the can's rim by gently pushing back (away from the piece) on the nozzle.

       

    Turn the can upside down.

    Push the button to squirt a small amount of clobetasol propionate foam, 0.05% into the cap of the can, onto a saucer or other cool surface, or your affected skin area. This amount should be no more than 1 1/2 capfuls, about the size of a golf ball.

    Do not squirt clobetasol propionate foam, 0.05% directly onto your hands (unless your hands are the affected areas), because the foam will begin to melt right away on contact with your warm skin.

    If your fingers are warm, rinse them in cold water first. (Be sure to dry them thoroughly before handling the foam.)

    If the can seems warm or the foam seems runny, run the can under cold water.

       

    Using your fingertips, gently massage clobetasol propionate foam, 0.05% into the affected areas until the foam disappears.

    If you are treating areas with hair such as the scalp, move any hair away so that the foam can be applied directly to the affected areas.

    Repeat the process until the affected areas are treated.

    Keep the foam away from your eyes, as it will sting and may cause eye problems if there is frequent contact with your eyes. If the foam gets your eyes, rinse them well with cold water right away. If the stinging continues, contact your doctor right away.

       

    Wash your hands after apply clobetasol propionate foam, 0.05%. Throw away any of the unused medicine that you squirted out of the can.