FDA records indicate that there are no current recalls for this drug.
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Questions & Answers
Side Effects & Adverse Reactions
WARNINGS: Not for prolonged use. If redness, pain, irritation or swelling persists, discontinue use and consult a physician. Contents of the container are under pressure. Do not burn or puncture the aerosol container. Do not store at temperatures above 120°F (49°C). Keep this and all medicines out of the reach of children.
Legal Issues
There is currently no legal information available for this drug.
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
INDICATIONS AND USAGE: Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
History
There is currently no drug history available for this drug.
Other Information
DESCRIPTION: Epifoam® (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) is a topical aerosol foam containing: hydrocortisone acetate 1% and pramoxine hydrochloride 1% in a base containing: propylene glycol, cetyl alcohol, glyceryl monostearate and PEG 100 stearate blend, laureth-23, polyoxyl-40 stearate, methylparaben, propylparaben, trolamine, purified water and inert propellants: isobutane and propane.
Epifoam® contains a synthetic corticosteroid used as an anti-inflammatory/antipruritic agent and a local anesthetic.
Hydrocortisone acetate
Molecular weight: 404.50. Solubility of hydrocortisone acetate in water: 1mg/100mL.
Chemical name: Pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-(11β)-.
Pramoxine hydrochloride
Molecular weight: 329.86. Pramoxine hydrochloride is freely soluble in water.
Chemical name: morpholine, 4-[3-(4-butoxyphenoxy) propyl]-, hydrochloride.
Sources
Epifoam Manufacturers
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Meda Pharmaceuticals
Epifoam | Meda Pharmaceuticals
DOSAGE AND ADMINISTRATION: Apply to affected area 3 to 4 times daily.
Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.
Directions For Use:
Shake the container vigorously for 5-10 seconds before each use. While holding container upright, prime the container by pressing down several times on container cap until foam appears. Apply a small amount directly to affected area 3-4 times daily depending on severity of the condition. Alternatively, dispense a small amount to a pad and apply to affected areas.
NOTE: The aerosol container should never be inserted into vagina or anus. The container and cap should be disassembled and rinsed with warm water after use.
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