PROCORT- 1.85% hydrocortisone acetate - 1.15% pramoxine hci cream cream

PROCORT by

Drug Labeling and Warnings

PROCORT by is a Prescription medication manufactured, distributed, or labeled by Womens Choice Pharmaceuticals LLC, Multipack Solutions. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

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

INGREDIENTS AND APPEARANCE

PROCORT 
1.85% hydrocortisone acetate - 1.15% pramoxine hci cream cream

Product 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)