Zeasorb
Miconazole Nitrate
Crown Laboratories
Human Otc Drug
NDC 0316-0231Zeasorb also known as Miconazole Nitrate is a human otc drug labeled by 'Crown Laboratories'. National Drug Code (NDC) number for Zeasorb is 0316-0231. This drug is available in dosage form of Powder. The names of the active, medicinal ingredients in Zeasorb drug includes Miconazole Nitrate - 20 mg/g . The currest status of Zeasorb drug is Active.
Drug Information:
| Drug NDC: | 0316-0231 |
| 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: | Zeasorb |
| 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: | Miconazole Nitrate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Crown Laboratories |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Powder |
| 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: | MICONAZOLE NITRATE - 20 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 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: | 14 Mar, 2011 |
| 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: | part333C |
| 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: | Crown Laboratories
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 998461
1437793
|
| 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: | VW4H1CYW1K
|
| 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: | Azole Antifungal [EPC]
Azoles [CS]
|
| 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 |
|---|
| 0316-0231-25 | 71 g in 1 BOTTLE (0316-0231-25) | 01 Dec, 2018 | 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 antifungal
Product Elements:
Zeasorb miconazole nitrate sodium acrylates crosspolymer-2 aldioxa chloroxylenol imidurea miconazole nitrate miconazole magnesium stearate microcrystalline cellulose croscarmellose sodium croscarmellose white to off-white zeasorb miconazole nitrate aldioxa chloroxylenol imidurea miconazole nitrate miconazole croscarmellose sodium croscarmellose magnesium stearate microcrystalline cellulose sodium acrylates crosspolymer-2 white to off-white
Indications and Usage:
Use (athlete's foot) for the cure of most athlete's foot
Use (jock itch) for the cure of most jock itch
Warnings:
Warnings for external use only. avoid contact with the eyes. do not use on children under 2 years of age unless directed by a doctor. stop use and ask a doctor if (athlete's foot) irritation occurs or there is no improvement within 4 weeks. stop use and ask a doctor if (jock itch) irritation occurs or there is no improvement within 2 weeks. 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. avoid contact with the eyes. do not use on children under 2 years of age unless directed by a doctor. stop use and ask a doctor if (athlete's foot) irritation occurs or there is no improvement within 4 weeks. stop use and ask a doctor if (jock itch) irritation occurs or there is no improvement within 2 weeks. keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.
Dosage and Administration:
Directions (athlete's foot) clean the affected area and dry thoroughly apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor supervise children in the use of this product pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily use daily for 4 weeks if condition persists longer, consult a doctor this product is not effective on the scalp or nails
Directions (jock itch) clean the affected area and dry thoroughly apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor supervise children in the use of this product use daily for 2 weeks if condition persists longer, consult a doctor this product is not effective on the scalp or nails
Stop Use:
Stop use and ask a doctor if (athlete's foot) irritation occurs or there is no improvement within 4 weeks.
Stop use and ask a doctor if (jock itch) irritation occurs or there is no improvement within 2 weeks.
Package Label Principal Display Panel:
Principal display panel ndc 0316-0231-25 zeasorb ® af antifungal treatment miconazole nitrate 2% super absorbent powder new & improved cures most athlete's foot absorbs & repels moisture relieves: itching burning scaling dermatologist recommended net wt. 2.5 oz (71 g) front label: p11546.01 athlete's foot
Principal display panel ndc 0316-0232-25 zeasorb ® af antifungal treatment miconazole nitrate 2% super absorbent powder new & improved cures most jock itch absorbs & repels moisture relieves: itching burning scaling dermatologist recommended net wt. 2.5 oz (71 g) front label: p11551.01 jock itch
Further Questions:
Questions or comments? call 1-833-279-6522 distributed by: crown laboratories, inc., johnson city, tn 37604 zeasorb is a registered trademark of crown laboratories, inc. p11552.01 ©2020 crown laboratories, inc.