Label: PROCORT- 1.85% hydrocortisone acetate - 1.15% pramoxine hci cream cream
- NDC Code(s): 50967-357-60
- Packager: Womens Choice Pharmaceuticals LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
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Drug Label Information
Updated January 18, 2023
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PATIENT PACKAGE INSERT
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.
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PRINCIPAL DISPLAY PANEL
ProCort carton for 60g
NDC 50967-357-60 Rx OnlySee 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
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INGREDIENTS AND APPEARANCE
PROCORT
1.85% hydrocortisone acetate - 1.15% pramoxine hci cream creamProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50967-357 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE ACETATE 18.5 mg in 1 g PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE 11.5 mg in 1 g Inactive Ingredients Ingredient Name Strength AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ) BUTYL ESTER OF METHYL VINYL ETHER-MALEIC ANHYDRIDE COPOLYMER (125 KD) (UNII: 389H2R62BD) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLOXAMER 124 (UNII: 1S66E28KXA) POLYSORBATE 60 (UNII: CAL22UVI4M) STEARIC ACID (UNII: 4ELV7Z65AP) WATER (UNII: 059QF0KO0R) ALPHA-TOCOPHEROL (UNII: H4N855PNZ1) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50967-357-60 1 in 1 CARTON 06/30/2011 1 1 in 1 TUBE, WITH APPLICATOR 1 60 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 06/30/2011 Labeler - Womens Choice Pharmaceuticals LLC (833067841) Registrant - Womens Choice Pharmaceuticals LLC (833067841) Establishment Name Address ID/FEI Business Operations Multipack Solutions 557434805 manufacture(50967-357)