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Procort Cream

Generic name: hydrocortisone acetate and pramoxine hydrochloride
Dosage form: cream
Drug class: Anorectal preparations

Medically reviewed by Drugs.com. Last updated on Aug 23, 2021.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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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.

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
1.85% hydrocortisone acetate - 1.15% pramoxine hci cream cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:50967-357
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCORTISONE ACETATE (HYDROCORTISONE) HYDROCORTISONE ACETATE 18.5 mg in 1 g
PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE HYDROCHLORIDE 11.5 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
AMINOMETHYL PROPANEDIOL
BUTYL ESTER OF METHYL VINYL ETHER-MALEIC ANHYDRIDE COPOLYMER (125 KD)
PHENOXYETHANOL
POLOXAMER 124
POLYSORBATE 60
STEARIC ACID
WATER
ALPHA-TOCOPHEROL
Product Characteristics
Color white Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description
1 NDC:50967-357-60 1 TUBE, WITH APPLICATOR in 1 CARTON
1 1 TUBE, WITH APPLICATOR in 1 TUBE, WITH APPLICATOR
1 60 g in 1 TUBE, WITH APPLICATOR
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 Operations
Multipack Solutions 557434805 manufacture(50967-357)
Womens Choice Pharmaceuticals LLC