PROCTOFOAM HC 100 mg/10g
pramoxine hydrochloride hydrocortisone acetate · AEROSOL, FOAM · Viatris Specialty LLC
PROCTOFOAM HC is a aerosol, foam containing pramoxine hydrochloride hydrocortisone acetate at 100 mg/10g, taken topical. Manufactured by Viatris Specialty LLC.
Key Facts
- Brand Name
- PROCTOFOAM HC
- Generic Name
- pramoxine hydrochloride hydrocortisone acetate
- NDC Code (Product)
0037-6822- Manufacturer
- Viatris Specialty LLC
- Strength
- 100 mg/10g
- Dosage Form
- AEROSOL, FOAM
- Route
- TOPICAL
- Marketing Status
- Application #
- ANDA086195
- Marketing Start
- 08/15/2014
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Proctofoam ® HC is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses of the anal region.
Dosage & Administration
DOSAGE AND ADMINISTRATION Apply to affected area 3 to 4 times daily. Use the applicator supplied for anal administration. For perianal use, transfer a small quantity to a tissue and rub in gently. Directions for Use. 1. Attach Cap: Place cap on top of container. 2. Shake Container: Shake foam container vigorously for 5-10 seconds before each use. Do not remove container cap during use of the product. 3. Attach Applicator: Hold container upright on a level surface and gently place the tip of the applicator onto the nose of the container cap. CONTAINER MUST BE HELD UPRIGHT TO OBTAIN PROPER FLOW OF MEDICATION. 4. Pull Plunger: Pull plunger past the fill line on the applicator barrel. 5. Prime Container: Hold the container and applicator at eye level. Place the index and middle fingers on the container cap flanges and the thumb beneath the container. Support the applicator with your other hand. Prime the container by pressing down firmly on flanges and then release. With initial priming, a burst of air may come out of the container. It usually requires 1-2 pumps for foam to appear. 6. Fill Applicator: To fill applicator barrel, press down firmly on cap flanges, hold for 1-2 seconds, an…
Warnings
WARNINGS Do not insert any part of the aerosol container directly into the anus. Avoid contact with the eyes. 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). If there is no evidence of clinical improvement within two or three weeks after starting Proctofoam ® HC therapy, or if the patient's condition worsens, discontinue the drug. Keep this and all medicines out of the reach of children.
Contraindications
CONTRAINDICATIONS Topical corticosteroid products are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
Adverse Reactions
ADVERSE REACTIONS 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 approximate 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 and miliaria. To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-866-210-5948 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Frequently Asked Questions
What is PROCTOFOAM HC used for?
PROCTOFOAM HC contains pramoxine hydrochloride hydrocortisone acetate. It is a aerosol, foam taken topical. Consult your doctor for specific uses.
Is PROCTOFOAM HC a controlled substance?
PROCTOFOAM HC is not classified as a controlled substance by the DEA.
What is the generic name for PROCTOFOAM HC?
The generic name for PROCTOFOAM HC is pramoxine hydrochloride hydrocortisone acetate. There are no other listed brand versions of pramoxine hydrochloride hydrocortisone acetate.
What is the NDC code for PROCTOFOAM HC 100 mg/10g?
The NDC (National Drug Code) for PROCTOFOAM HC 100 mg/10g is 0037-6822, listed by Viatris Specialty LLC.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)