Mckesson Bacitracin Zinc
Bacitracin Zinc
Mckesson
Human Otc Drug
NDC 68599-1184Mckesson Bacitracin Zinc also known as Bacitracin Zinc is a human otc drug labeled by 'Mckesson'. National Drug Code (NDC) number for Mckesson Bacitracin Zinc is 68599-1184. This drug is available in dosage form of Ointment. The names of the active, medicinal ingredients in Mckesson Bacitracin Zinc drug includes Bacitracin Zinc - 500 [iU]/g . The currest status of Mckesson Bacitracin Zinc drug is Active.
Drug Information:
| Drug NDC: | 68599-1184 |
| 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: | Mckesson Bacitracin Zinc |
| 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: | Bacitracin Zinc |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Mckesson |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Ointment |
| 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: | BACITRACIN ZINC - 500 [iU]/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: | 01 Feb, 2019 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 01 Jul, 2024 |
| 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: | M004 |
| 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: | 16 Jan, 2025 |
| 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: | McKesson
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1366116
|
| 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. |
| UPC: | 0612479243453
|
| UPC stands for Universal Product Code. |
| UNII: | 89Y4M234ES
|
| 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: | Decreased Cell Wall Synthesis & Repair [PE]
|
| 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 |
|---|
| 68599-1184-4 | 28 g in 1 TUBE (68599-1184-4) | 01 Feb, 2019 | 01 Jul, 2024 | 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:
Uses: first aid to help prevent infection in: minor cuts scrapes burns
Product Elements:
Mckesson bacitracin zinc bacitracin zinc mineral oil petrolatum bacitracin zinc bacitracin
Indications and Usage:
Do not use: in the eyes if you are allergic to any of the ingredients, due to the possibility of anaphylactic shock over large areas of the body longer than 1 week unless directed by a doctor
Warnings:
Warnings: for external use only
Dosage and Administration:
Directions: clean the affected area. apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily. may be covered with a sterile bandage.
Stop Use:
Stop use and ask a doctor before use in case of deep puncture wounds, animal bites or serious burns the condition persists or gets worse if a rash or other allergic reaction develops
Package Label Principal Display Panel:
Ndc 68599-1184-4 mckesson bacitracin zinc ointment first aid antibiotic to help prevent infection. net weight 1 oz (28 g) mfr # 118-15472 118-15472 each
Ndc 68599-1184-4 mckesson bacitracin zinc ointment first aid antibiotic to help prevent infection. net weight 1 oz (28 g) 1 per box mfr # 118-15472 118-15472 box
Ndc 68599-1184-4 mckesson bacitracin zinc ointment first aid antibiotic to help prevent infection. net weight 1 oz (28 g) 1 per box / 24 boxes per case store at 59-86ºf (15-30ºc). avoid excessive heat and humidity. not made with natural rubber latex. distributed by mckesson medical-surgical inc. richmond, va 23233 pvn a0219 made in usa mfr # 118-15472 118-15472 case
Further Questions:
Questions? call 1-800-777-4908