Equate Lubricant Eye Stye
Mineral Oil And Petrolatum
Wal-mart Stores Inc
Human Otc Drug
NDC 79903-028Equate Lubricant Eye Stye also known as Mineral Oil And Petrolatum is a human otc drug labeled by 'Wal-mart Stores Inc'. National Drug Code (NDC) number for Equate Lubricant Eye Stye is 79903-028. This drug is available in dosage form of Ointment. The names of the active, medicinal ingredients in Equate Lubricant Eye Stye drug includes Mineral Oil - 319 mg/g Petrolatum - 577 mg/g . The currest status of Equate Lubricant Eye Stye drug is Active.
Drug Information:
| Drug NDC: | 79903-028 |
| 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: | Equate Lubricant Eye Stye |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Equate Lubricant Eye |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | STYE |
| 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: | Mineral Oil And Petrolatum |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Wal-mart Stores Inc |
| 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: | MINERAL OIL - 319 mg/g
PETROLATUM - 577 mg/g
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | OPHTHALMIC
|
| 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: | 13 Sep, 2021 |
| 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: | part349 |
| 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: | WAL-MART STORES INC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 579999
|
| 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: | T5L8T28FGP
4T6H12BN9U
|
| 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 |
|---|
| 79903-028-35 | 1 TUBE in 1 BOX (79903-028-35) / 3.5 g in 1 TUBE | 13 Sep, 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 emollient
Purpose emollient
Product Elements:
Equate lubricant eye stye mineral oil and petrolatum microcrystalline wax stearic acid wheat germ oil mineral oil mineral oil petrolatum petrolatum clear
Indications and Usage:
Uses temporarily relieves burning and irritation of the eye and discomfort due to dryness of the eye or exposure to wind or sun as use as a protectant against further irritation
Warnings:
Warnings for external use only when using this product to avoid contamination do not touch tip of container to any surface replace cap after use stop use and ask a doctor if you experience eye pain, changes in vision, continued redness or irritation of the eye condition worsens condition persists for more than 72 hours keep out of reach of children. if swallowed, get medical help or contact a poison control center right away. 1-800-222-1222
When Using:
When using this product to avoid contamination do not touch tip of container to any surface replace cap after use
Dosage and Administration:
Directions pull down the lower lid of the affected eye and apply a small amount (one-fourth inch) of ointment to the inside of the eyelid
Stop Use:
Stop use and ask a doctor if you experience eye pain, changes in vision, continued redness or irritation of the eye condition worsens condition persists for more than 72 hours
Package Label Principal Display Panel:
Principal display panel st