1.85% Hydrocortisone Acetate - 1.15% Pramoxine Hci Cream
FDA Drug Information • Also known as: Procort
- Brand Names
- Procort
- Route
- TOPICAL
- Dosage Form
- CREAM
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
DESCRIPTION: ProCort® is a topical preparation containing hydrocortisone acetate 1.85% and pramoxine hydrochloride 1.15% in a hydrophilic and hydrophobic cream base which contains patented *Invisicare M1 polymer technology. Active Ingredients: Hydrocortisone Acetate 1.85%, Pramoxine HCL 1.15% Inactive Ingredients: Polysorbate-60, Poloxamer 124, PVM/MA copolymer VP/Hexadecene copolymer VP/Eicosene copolymer, Tocopheryl acetate, Aminomethyl propanediol, Stearic Acid, Phenoxyethanol, and Sterilized Water. Topical corticosteroids are anti-inflammatory and anti-pruritic agents. The structural formula, the chemical name, molecular formula and molecular weight for active ingredients are presented below. formula
What Is 1.85% Hydrocortisone Acetate - 1.15% Pramoxine Hci Cream Used For?
Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Dosage and Administration
topical corticosteroids are generally applied to the affected area as a thin film 3 to 4 times daily, depending on the severity of the condition. Occlusive dressing 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 rectal administration: 1. To open, remove foil, tab or puncture foil seal with cap. 2. Remove the applicator’s wrapping and attach the applicator to the tube. 3. Squeeze the tube to fill the applicator and lubricate the tip with cream. 4. Gently insert the applicator into rectum and squeeze tube begin to force the required amount of cream into rectum. 5. Wipe applicator tip clean remove and discard. 6. Securely apply screw cap on tube.
Side Effects (Adverse Reactions)
The following local adverse reactions are reported in frequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence; itching, burning, skin irritation.
Contraindications
Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
Overdosage
topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects. (See precautions.)
How Supplied
hydrocortisone acetate 1.85%, Pramoxine HCL 1.15% is a topical cream and supplied in the following: 60 gram tube kit (NDC# 50967–357–60), each containing a 60 g tube and/15 single use app applicators. 2 gram Sample Kit (NDC# 50967–357–02), each containing a 2g tube and/1 single use applicator
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.