Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Epifoam ® is supplied in 10 g pressurized cans. NDC 0037-6824-10 10 g Store upright at controlled room temperature 20° – 25°C (68° – 77°F). DO NOT REFRIGERATE. Distributed by: Meda Pharmaceuticals Inc. Canonsburg, PA 15317 U.S.A. © 2024 Viatris Inc. For Medical Inquiries, call toll-free 1-877-848-6610 EPIFOAM is a registered trademark of Alaven Pharmaceutical LLC, a Viatris Company. IN-682410-05 141341-0224; PRINCIPAL DISPLAY PANEL NDC 0037-6824-10 epifoam ® (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) topical aerosol Rx Only MEDA 10 g net wt Description: 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, puried water, and inert propellants: isobutane and propane. WARNINGS: 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). Directions for Use See package insert for full prescribing information. 1. Shake the container vigorously for 5-10 seconds before each use. 2. While holding container upright, prime the container by pressing down several times on container cap until foam appears. Apply a small amount directly to a‑ected areas 3-4 times daily depending on severity of the condition. Alternatively, dispense a small amount to a pad and apply to a‑ected areas. NOTE: The aerosol container should never be inserted into vagina or anus. 3. The container and cap should be disassembled and rinsed with warm water after use. Distributed by: Meda Pharmaceuticals Inc. Canonsburg, PA 15317 U.S.A. ©2024 Viatris Inc. EPIFOAM is a registered trademark of Alaven Pharmaceutical LLC, a Viatris company. KEEP OUT OF REACH OF CHILDREN. FOR EXTERNAL USE ONLY. Store upright at controlled room temperature 20° - 25°C (68° - 77°F). DO NOT REFRIGERATE. 117751-0224 UC-682410-04 Epifoam Carton Label
- HOW SUPPLIED Epifoam ® is supplied in 10 g pressurized cans. NDC 0037-6824-10 10 g Store upright at controlled room temperature 20° – 25°C (68° – 77°F). DO NOT REFRIGERATE. Distributed by: Meda Pharmaceuticals Inc. Canonsburg, PA 15317 U.S.A. © 2024 Viatris Inc. For Medical Inquiries, call toll-free 1-877-848-6610 EPIFOAM is a registered trademark of Alaven Pharmaceutical LLC, a Viatris Company. IN-682410-05 141341-0224
- PRINCIPAL DISPLAY PANEL NDC 0037-6824-10 epifoam ® (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) topical aerosol Rx Only MEDA 10 g net wt Description: 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, puried water, and inert propellants: isobutane and propane. WARNINGS: 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). Directions for Use See package insert for full prescribing information. 1. Shake the container vigorously for 5-10 seconds before each use. 2. While holding container upright, prime the container by pressing down several times on container cap until foam appears. Apply a small amount directly to a‑ected areas 3-4 times daily depending on severity of the condition. Alternatively, dispense a small amount to a pad and apply to a‑ected areas. NOTE: The aerosol container should never be inserted into vagina or anus. 3. The container and cap should be disassembled and rinsed with warm water after use. Distributed by: Meda Pharmaceuticals Inc. Canonsburg, PA 15317 U.S.A. ©2024 Viatris Inc. EPIFOAM is a registered trademark of Alaven Pharmaceutical LLC, a Viatris company. KEEP OUT OF REACH OF CHILDREN. FOR EXTERNAL USE ONLY. Store upright at controlled room temperature 20° - 25°C (68° - 77°F). DO NOT REFRIGERATE. 117751-0224 UC-682410-04 Epifoam Carton Label
Overview
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. Hydrocortisone Acetate Structural Formula Pramoxine Hydrochloride Structural Formula
Indications & Usage
Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Dosage & 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: 1. Shake the container vigorously for 5-10 seconds before each use. 2. 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. 3. The container and cap should be disassembled and rinsed with warm water after use.
Warnings & Precautions
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.
Contraindications
Topical corticosteroid products are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
Adverse Reactions
To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-877-848-6610 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximately decreasing order of occurrence: Burning, Itching, Irritation, Dryness, Folliculitis, Hypertrichosis, Acneiform eruptions, Hypopigmentation, Perioral dermatitis, Allergic contact dermatitis, Maceration of the skin, Secondary infection, Skin atrophy, Striae, Miliaria
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