Procort
1.85% Hydrocortisone Acetate - 1.15% Pramoxine Hci Cream
Womens Choice Pharmaceuticals Llc
Human Prescription Drug
NDC 50967-357Procort also known as 1.85% Hydrocortisone Acetate - 1.15% Pramoxine Hci Cream is a human prescription drug labeled by 'Womens Choice Pharmaceuticals Llc'. National Drug Code (NDC) number for Procort is 50967-357. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Procort drug includes Hydrocortisone Acetate - 18.5 mg/g Pramoxine Hydrochloride - 11.5 mg/g . The currest status of Procort drug is Active.
Drug Information:
| Drug NDC: | 50967-357 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Procort |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | 1.85% Hydrocortisone Acetate - 1.15% Pramoxine Hci Cream |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Womens Choice Pharmaceuticals Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Cream |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | HYDROCORTISONE ACETATE - 18.5 mg/g
PRAMOXINE HYDROCHLORIDE - 11.5 mg/g
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TOPICAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | UNAPPROVED DRUG OTHER |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 30 Jun, 2011 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 20 Jan, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Listing Expiration Date: | 31 Dec, 2024 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Womens Choice Pharmaceuticals LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1114854
1115730
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | 3X7931PO74
88AYB867L5
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class: | Corticosteroid Hormone Receptor Agonists [MoA]
Corticosteroid [EPC]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 50967-357-60 | 1 TUBE, WITH APPLICATOR in 1 CARTON (50967-357-60) / 1 TUBE, WITH APPLICATOR in 1 TUBE, WITH APPLICATOR / 60 g in 1 TUBE, WITH APPLICATOR | 30 Jun, 2011 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Procort 1.85% hydrocortisone acetate - 1.15% pramoxine hci cream aminomethyl propanediol butyl ester of methyl vinyl ether-maleic anhydride copolymer (125 kd) phenoxyethanol poloxamer 124 polysorbate 60 stearic acid water alpha-tocopherol hydrocortisone acetate hydrocortisone pramoxine hydrochloride pramoxine
Description:
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.
Spl Patient Package Insert:
Procort ® packageinsert secondpage 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:
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