Zcort Ultra
Hydrocortisone Acetate 1%
Rxdino, Llc
Human Otc Drug
NDC 81335-532Zcort Ultra also known as Hydrocortisone Acetate 1% is a human otc drug labeled by 'Rxdino, Llc'. National Drug Code (NDC) number for Zcort Ultra is 81335-532. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Zcort Ultra drug includes Hydrocortisone Acetate - 10 mg/g . The currest status of Zcort Ultra drug is Active.
Drug Information:
| Drug NDC: | 81335-532 |
| 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: | Zcort Ultra |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Zcort |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Ultra |
| A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. |
| 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 1% |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Rxdino, 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 - 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: | 01 Mar, 2021 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 06 May, 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. |
| 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: | RxDino, LLC
|
| 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. |
| 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 |
|---|
| 81335-532-15 | 15 g in 1 BOX (81335-532-15) | 01 Mar, 2021 | 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:
Zcort ultra hydrocortisone acetate 1% phenoxyethanol prasterone hydrocortisone acetate hydrocortisone aloe vera leaf polysorbate 60 tocopherol stearic acid coconut oil jojoba oil water sunflower oil xanthan gum glycerin cetostearyl alcohol
Indications and Usage:
Uses temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to: eczema psoriasis poison ivy, oak, sumac insect bites detergents jewelry cosmetics soaps seborrheic dermatitis temporarily relieves external anal and genital itching other uses of this product should only be under the advice and supervision of a doctor
Warnings:
Warnings for external use only
Do Not Use:
Warnings for external use only
When Using:
When using this product avoid contact with eyes do not use more than directed unless told to do so by a doctor do not put directly into the rectum by using fingers or any mechanical device or applicator
Dosage and Administration:
Directions for itching of skin irritation, inflammation, and rashes adults and children 12 years of age and older apply to affected area not more than 2 to 3 times daily for external anal and genital itching, adults when practical, clean the affected area with mild soap and warm water and rinse thoroughly gently dry by patting or blotting with toilet tissue or a soft cloth before applying apply to affected area not more than 2 to 3 times daily ages 12 to 18 years: ask a doctor
Stop Use:
Stop use and ask a doctor if condition worsens or persists for more than 7 days if condition clears up and occurs again if rectal bleeding occurs before using any other hydrocortisone product
Package Label Principal Display Panel:
Front display panel and back card new! formulated to heal itch and protect collagen steroid power fast acting rash poison ivy eczema insect bites psoriasis inflammation unique patented formula zcort ultra+ anti-itch cream net wt 0.5 oz (15g) active ingredient: hydrocortizone 1% with dhea see zcortfront.jpg zcort ultra+ anti-itch cream back card see zcortbackbox.jpg front display panel back card