PROCORT (hydrocortisone acetate and pramoxine hydrochloride) cream
SPL PATIENT PACKAGE INSERT SECTION
PROCORT ®
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.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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