Drug Facts
Composition & Profile
Identifiers & Packaging
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; label ProCort carton for 60g NDC 50967-357-60 Rx Only See product literature for complete information. Contents: Each gram of ProCort contains 1.85% (18.5 mg) Hydrocortisone acetate and 1.15% (11.5 mg) Pramoxine hydrochloride (HCI). Also contains 6% M1 polymer. Inactive ingredients: Polysorbate-60, Poloxamer 124, PVM/MA copolymer VP/Hexadecene copolymer VP/Eicosene copolymer, Tocopheryl acetate, Aminomethyl propanediol, Stearic Acid, Phenoxyenthanol, and Sterilized Water. Dosage: Apply to affected are 3 - 4 times daily or as directed by your physician Warning: Keep out of reach of children. Not fur use under diapers or occlusive dressings without physician supervision. for externam use only. Avoid contact with eyes. May discolor fabrics. Storage: Store at room temperature 15°-30°C (59°-86°F). Keep tightly closed. To Open: Remove foil tab or puncture foil seal with cap. Applicator: Use applicator tip as directed by your physician. 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 libricate the tip with cream. 4. Gently insert the applicator into rectum and squeeze tube again to force the required amount of cream into rectum. 5. Wipe applicator tip clean, remove and discard. 6. Securely apply screw cap on tube. NDC 50967-357-60 ProCort 1.85% hydrocortisone acetate - 1.15% pramoxine HCI FOR EXTERNAL USE ONLY Net Weight 60.0g (2.12 oz) Distributed by: Women's Choice Pharmaceuticals, Gilbert, AZ 85233 www.wcpharma.com 877-774-4949 Invisicare® M1 Plymer Patent Numbers: 7,674,471, 6,756,059, 6,582,683; ProCort carton for 60g NDC 50967-357-60 Rx Only See product literature for complete information. Contents: Each gram of ProCort contains 1.85% (18.5 mg) Hydrocortisone acetate and 1.15% (11.5 mg) Pramoxine hydrochloride (HCI). Also contains 6% M1 polymer. Inactive ingredients: Polysorbate-60, Poloxamer 124, PVM/MA copolymer VP/Hexadecene copolymer VP/Eicosene copolymer, Tocopheryl acetate, Aminomethyl propanediol, Stearic Acid, Phenoxyenthanol, and Sterilized Water. Dosage: Apply to affected are 3 - 4 times daily or as directed by your physician Warning: Keep out of reach of children. Not fur use under diapers or occlusive dressings without physician supervision. for externam use only. Avoid contact with eyes. May discolor fabrics. Storage: Store at room temperature 15°-30°C (59°-86°F). Keep tightly closed. To Open: Remove foil tab or puncture foil seal with cap. Applicator: Use applicator tip as directed by your physician. 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 libricate the tip with cream. 4. Gently insert the applicator into rectum and squeeze tube again to force the required amount of cream into rectum. 5. Wipe applicator tip clean, remove and discard. 6. Securely apply screw cap on tube. NDC 50967-357-60 ProCort 1.85% hydrocortisone acetate - 1.15% pramoxine HCI FOR EXTERNAL USE ONLY Net Weight 60.0g (2.12 oz) Distributed by: Women's Choice Pharmaceuticals, Gilbert, AZ 85233 www.wcpharma.com 877-774-4949 Invisicare® M1 Plymer Patent Numbers: 7,674,471, 6,756,059, 6,582,683
- 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
- label ProCort carton for 60g NDC 50967-357-60 Rx Only See product literature for complete information. Contents: Each gram of ProCort contains 1.85% (18.5 mg) Hydrocortisone acetate and 1.15% (11.5 mg) Pramoxine hydrochloride (HCI). Also contains 6% M1 polymer. Inactive ingredients: Polysorbate-60, Poloxamer 124, PVM/MA copolymer VP/Hexadecene copolymer VP/Eicosene copolymer, Tocopheryl acetate, Aminomethyl propanediol, Stearic Acid, Phenoxyenthanol, and Sterilized Water. Dosage: Apply to affected are 3 - 4 times daily or as directed by your physician Warning: Keep out of reach of children. Not fur use under diapers or occlusive dressings without physician supervision. for externam use only. Avoid contact with eyes. May discolor fabrics. Storage: Store at room temperature 15°-30°C (59°-86°F). Keep tightly closed. To Open: Remove foil tab or puncture foil seal with cap. Applicator: Use applicator tip as directed by your physician. 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 libricate the tip with cream. 4. Gently insert the applicator into rectum and squeeze tube again to force the required amount of cream into rectum. 5. Wipe applicator tip clean, remove and discard. 6. Securely apply screw cap on tube. NDC 50967-357-60 ProCort 1.85% hydrocortisone acetate - 1.15% pramoxine HCI FOR EXTERNAL USE ONLY Net Weight 60.0g (2.12 oz) Distributed by: Women's Choice Pharmaceuticals, Gilbert, AZ 85233 www.wcpharma.com 877-774-4949 Invisicare® M1 Plymer Patent Numbers: 7,674,471, 6,756,059, 6,582,683
- ProCort carton for 60g NDC 50967-357-60 Rx Only See product literature for complete information. Contents: Each gram of ProCort contains 1.85% (18.5 mg) Hydrocortisone acetate and 1.15% (11.5 mg) Pramoxine hydrochloride (HCI). Also contains 6% M1 polymer. Inactive ingredients: Polysorbate-60, Poloxamer 124, PVM/MA copolymer VP/Hexadecene copolymer VP/Eicosene copolymer, Tocopheryl acetate, Aminomethyl propanediol, Stearic Acid, Phenoxyenthanol, and Sterilized Water. Dosage: Apply to affected are 3 - 4 times daily or as directed by your physician Warning: Keep out of reach of children. Not fur use under diapers or occlusive dressings without physician supervision. for externam use only. Avoid contact with eyes. May discolor fabrics. Storage: Store at room temperature 15°-30°C (59°-86°F). Keep tightly closed. To Open: Remove foil tab or puncture foil seal with cap. Applicator: Use applicator tip as directed by your physician. 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 libricate the tip with cream. 4. Gently insert the applicator into rectum and squeeze tube again to force the required amount of cream into rectum. 5. Wipe applicator tip clean, remove and discard. 6. Securely apply screw cap on tube. NDC 50967-357-60 ProCort 1.85% hydrocortisone acetate - 1.15% pramoxine HCI FOR EXTERNAL USE ONLY Net Weight 60.0g (2.12 oz) Distributed by: Women's Choice Pharmaceuticals, Gilbert, AZ 85233 www.wcpharma.com 877-774-4949 Invisicare® M1 Plymer Patent Numbers: 7,674,471, 6,756,059, 6,582,683
Overview
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
Indications & Usage
Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Dosage & 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.
Warnings & Precautions
No warnings available yet.
Contraindications
Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
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.
Storage & Handling
ProCort® insert registered symbol,storage condition: store at 25°C (77°F); excursions permitted to 15–30°C (59 to 86°F.)[see USP controlled room temperature]. Rx only. Distributed by: Women’s Choice, Pharmaceuticals, Berwyn, PA 19312 Www.wcpharma.com
Similar Drugs
Related medications based on brand, generic name, substance, active ingredients.