Hydrocortisone
Hydrocortisone Acetate
Jhk Inc Dba American Safety & First Aid
Human Otc Drug
NDC 73598-1014Hydrocortisone also known as Hydrocortisone Acetate is a human otc drug labeled by 'Jhk Inc Dba American Safety & First Aid'. National Drug Code (NDC) number for Hydrocortisone is 73598-1014. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Hydrocortisone drug includes Hydrocortisone Acetate - .9 g/.9g . The currest status of Hydrocortisone drug is Active.
Drug Information:
| Drug NDC: | 73598-1014 |
| 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: | Hydrocortisone |
| 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: | Jhk Inc Dba American Safety & First Aid |
| 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 - .9 g/.9g
|
| 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: | 02 Feb, 2000 |
| 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, 2023 |
| 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: | JHK Inc dba American Safety & First Aid
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0747200610140
|
| UPC stands for Universal Product Code. |
| UNII: | 3X7931PO74
|
| 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 |
|---|
| 73598-1014-1 | 25 PACKET in 1 CARTON (73598-1014-1) / 1 g in 1 PACKET | 02 Feb, 2000 | 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 cream
Product Elements:
Hydrocortisone hydrocortisone acetate hydrocortisone acetate hydrocortisone cetostearyl alcohol polyoxyl 20 cetostearyl ether petrolatum water
Indications and Usage:
Use temporarily relieves itching associated with minor skin irritations and rashes due to: eczema insect bites poison ivy, oak or sumac soaps, detergents or cosmetics jewelry
Warnings:
Warnings for external use only do not use with any other hydrocortisone product unless you have consulted a doctor for the treatment of diaper rash, consult a doctor stop use and ask a doctor if condition worsens symptoms persist for more than seven days symptoms clear up and occur again within a few days 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 with any other hydrocortisone product unless you have consulted a doctor for the treatment of diaper rash, consult a doctor stop use and ask a doctor if condition worsens symptoms persist for more than seven days symptoms clear up and occur again within a few days keep out of reach of children if swallowed, get medical help or contact a poison control center right away.
Dosage and Administration:
Directions adults and children two years and over: apply to affected area not more than three to four times daily children under two years: do not use
Stop Use:
Stop use and ask a doctor if condition worsens symptoms persist for more than seven days symptoms clear up and occur again within a few days
Package Label Principal Display Panel:
Principal display panel - 25 packet carton product #1014 hydrocortisone cream usp 1% for the temporary relief of itching associated with minor skin irritations and rashes. 25 - unit dose packets principal display panel - 25 packet carton
Further Questions:
Questions? 1-866-651-3660 monday-friday 8:00am-5:00pm est