Australian Gold Defense Zone Anti-dandruff Leave-in Treatment
Pyrithione Zinc
Prime Enterprises, Inc.
Human Otc Drug
NDC 58443-0186Australian Gold Defense Zone Anti-dandruff Leave-in Treatment also known as Pyrithione Zinc is a human otc drug labeled by 'Prime Enterprises, Inc.'. National Drug Code (NDC) number for Australian Gold Defense Zone Anti-dandruff Leave-in Treatment is 58443-0186. This drug is available in dosage form of Lotion. The names of the active, medicinal ingredients in Australian Gold Defense Zone Anti-dandruff Leave-in Treatment drug includes Pyrithione Zinc - 2.14 mg/mL . The currest status of Australian Gold Defense Zone Anti-dandruff Leave-in Treatment drug is Active.
Drug Information:
| Drug NDC: | 58443-0186 |
| 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: | Australian Gold Defense Zone Anti-dandruff Leave-in Treatment |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Australian Gold Defense Zone |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Anti-dandruff Leave-in Treatment |
| 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: | Pyrithione Zinc |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Prime Enterprises, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Lotion |
| 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: | PYRITHIONE ZINC - 2.14 mg/mL
|
| 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 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 Aug, 2015 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 16 Jun, 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: | part358H |
| 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: | Prime Enterprises, Inc.
|
| 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. |
| UNII: | R953O2RHZ5
|
| 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. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 58443-0186-3 | 59 mL in 1 BOTTLE (58443-0186-3) | 01 Aug, 2015 | 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 antidanruff
Product Elements:
Australian gold defense zone anti-dandruff leave-in treatment pyrithione zinc caprylyl glycol polyoxyl 20 cetostearyl ether cetostearyl alcohol cetyl alcohol cetrimonium bromide chlorphenesin citric acid monohydrate edetate disodium palm oil glycerin phenoxyethanol sodium hydroxide guar hydroxypropyltrimonium chloride (1.7 substituents per saccharide) water pyrithione zinc pyrithione zinc
Indications and Usage:
Indications: controls the symptoms of dandruff. helps prevent recurrence of scalp itching and flaking associated with dandruff.
Warnings:
Warning: for external use only. when using this product avoid contact with the eyes. if contact occurs, rinse eyes thorougly with water. stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed. keep out of reach of children. if swallowed, get medical help or contact a poison control center right away
When Using:
When using this product avoid contact with the eyes. if contact occurs, rinse eyes thorougly with water.
Dosage and Administration:
Directions: shake well. use after shampooing and towel drying hair. part hair section by section. apply directly onto the scalp and spread using fingertips. gently massage into scalp. leave in. apply to affected areas one to four times daily or as directed by a doctor children under 6 months of age: ask a doctor.
Stop Use:
Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed.
Package Label Principal Display Panel:
Principal display panel - 59 ml bottle label defense zone medicated leave-in treatment anti-dandruff step 3 relieves dryness 2 fl oz (59ml) principal display panel - 59 ml bottle label
Further Questions:
Questions or comments? call toll free 1-855-548-4653