Leader Hydrocortisone With Aloe
Hydrocortisone
Leader
Human Otc Drug
NDC 70000-0543Leader Hydrocortisone With Aloe also known as Hydrocortisone is a human otc drug labeled by 'Leader'. National Drug Code (NDC) number for Leader Hydrocortisone With Aloe is 70000-0543. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Leader Hydrocortisone With Aloe drug includes Hydrocortisone - .01 g/g . The currest status of Leader Hydrocortisone With Aloe drug is Active.
Drug Information:
| Drug NDC: | 70000-0543 |
| 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: | Leader Hydrocortisone With Aloe |
| 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 |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Leader |
| 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 - .01 g/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 Jan, 2020 |
| 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: | LEADER
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 106258
|
| 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. |
| NUI: | N0000175576
N0000175450
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | WI4X0X7BPJ
|
| 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 MOA: | Corticosteroid Hormone Receptor Agonists [MoA]
|
| Mechanism of action of the drug—molecular, subcellular, or cellular functional activity—of the drug’s established pharmacologic class. Takes the form of the mechanism of action, followed by `[MoA]` (such as `Calcium Channel Antagonists [MoA]` or `Tumor Necrosis Factor Receptor Blocking Activity [MoA]`. |
| Pharmacologic Class EPC: | Corticosteroid [EPC]
|
| Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`. |
| 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 |
|---|
| 70000-0543-1 | 1 TUBE in 1 CARTON (70000-0543-1) / 28 g in 1 TUBE | 17 Jan, 2020 | 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 antipruritic (anti-itch)
Product Elements:
Leader hydrocortisone with aloe hydrocortisone hydrocortisone hydrocortisone aloe vera leaf carbomer homopolymer, unspecified type cetyl alcohol dmdm hydantoin glyceryl monostearate isopropyl alcohol methylparaben mineral oil polysorbate 20 propylparaben water stearic acid trolamine edetate trisodium
Indications and Usage:
Uses for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry and for external anal and genital itching.
Warnings:
Warnings for external use only. avoid contact with eyes. do not use if you have a vaginal discharge. consult a doctor. when using this product do not exceed the recommended daily dosage unless directed by a doctor do not put into the rectum by using fingers or any mechanical device or applicator stop use and ask a doctor if condition worsens symptoms persist for more than 7 days or clear up and occurs again within a few days bleeding occurs if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. if swallowed, get medical help or contact a poison control center right away: 800-222-1222.
Do Not Use:
Warnings for external use only. avoid contact with eyes. do not use if you have a vaginal discharge. consult a doctor. when using this product do not exceed the recommended daily dosage unless directed by a doctor do not put into the rectum by using fingers or any mechanical device or applicator stop use and ask a doctor if condition worsens symptoms persist for more than 7 days or clear up and occurs again within a few days bleeding occurs if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. if swallowed, get medical help or contact a poison control center right away: 800-222-1222.
When Using:
When using this product do not exceed the recommended daily dosage unless directed by a doctor do not put into the rectum by using fingers or any mechanical device or applicator
Dosage and Administration:
Directions for itching associated with minor skin irritations, inflammation, and rashes: adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily children under 2 years of age: consult a doctor for external anal and genital itching: adults and children 12 years of age and older: when practical, cleanse the affected area with mild soap or warm water and rinse thoroughly or by patting or blotting with an appropriate cleansing pad gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product apply to affected area not more than 3 to 4 times daily children under 12 years of age: consult a doctor
Stop Use:
Stop use and ask a doctor if condition worsens symptoms persist for more than 7 days or clear up and occurs again within a few days bleeding occurs
Package Label Principal Display Panel:
Principal display panel - 28 g tube carton ndc 70000-0543-1 leader maximum strength hydrocortisone cream with aloe hydrocortisone, 1% | anti-itch compare to cortizone-10® with aloe maximum strength active ingredient* 100% money back guarantee fast itch relief relief in a soothing cream eczema insect bites psoriasis poison ivy, oak & sumac seborrheic dermatitis soaps and more net wt 1 oz (28 g) principal display panel - 28 g tube carton
Further Questions:
Questions or comments? 866-323-0107 or www.natureplex.com