Medi-first
Hydrocortisone Acetate
Orazen Inc
Human Otc Drug
NDC 71927-018Medi-first also known as Hydrocortisone Acetate is a human otc drug labeled by 'Orazen Inc'. National Drug Code (NDC) number for Medi-first is 71927-018. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Medi-first drug includes Hydrocortisone Acetate - 10 mg/g . The currest status of Medi-first drug is Active.
Drug Information:
| Drug NDC: | 71927-018 |
| 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: | Medi-first |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc 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: | Hydrocortisone Acetate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Orazen Inc |
| 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 - 10 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: | OTC MONOGRAPH NOT FINAL |
| 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: | 17 Feb, 2023 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 15 Jan, 2025 |
| 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. |
| Application Number: | part348 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| 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: | |
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| UNII: | |
| 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 |
|---|
| 71927-018-04 | 25 POUCH in 1 BOX (71927-018-04) / .9 g in 1 POUCH (71927-018-01) | 17 Feb, 2023 | 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. |
Purpose:
Purpose anti-itch
Product Elements:
Medi-first hydrocortisone acetate petrolatum polyoxyl 20 cetostearyl ether cetostearyl alcohol glyceryl 1-stearate ethylhexylglycerin phenoxyethanol glycerin mineral oil water hydrocortisone acetate hydrocortisone
Indications and Usage:
Uses for the temporary relief of itching associated with minor skin irritation,inflammation and rashed due to eczema, insect bites, poison ivy, poison oak,poison sumac, soaps, detergents, cosmetics,jewelry, sebortheic dermatitis, psoriasis and scrapes other uses of this product should be only under the advice and supervision of a doctor
Warnings:
Warnings for external use only do not use for treatment of diaper rash in eyes for feminine itching stop use and ask a doctor if condition worsens or lasts more than 7 days, or clears up and occurs again within a few days you begin use of any other hydrocortisone product bleeding occurs keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.
Do Not Use:
Warnings for external use only do not use for treatment of diaper rash in eyes for feminine itching stop use and ask a doctor if condition worsens or lasts more than 7 days, or clears up and occurs again within a few days you begin use of any other hydrocortisone product bleeding occurs keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.
Dosage and Administration:
Directions for adults and children 2 years of age and older: apply to affected area 3 to 4 times daily ?children under 12 years of age: for external anal itching, consult a doctor children under 2 years of age: do not use, consult a doctor adults for external anal itching when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with an appropriate cleansing pad (continued on side panel) gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
Stop Use:
Stop use and ask a doctor if condition worsens or lasts more than 7 days, or clears up and occurs again within a few days you begin use of any other hydrocortisone product bleeding occurs
Package Label Principal Display Panel:
Package labeling: image of pouch label image of box label
Further Questions:
Questions or comments? 1-800-634-7680