Visco Shield Lubricant
Hypromellose 2208 (15000 Mpa.s)
Oasis Medical, Inc.
Human Otc Drug
NDC 42126-5200Visco Shield Lubricant also known as Hypromellose 2208 (15000 Mpa.s) is a human otc drug labeled by 'Oasis Medical, Inc.'. National Drug Code (NDC) number for Visco Shield Lubricant is 42126-5200. This drug is available in dosage form of Solution/ Drops. The names of the active, medicinal ingredients in Visco Shield Lubricant drug includes Hypromellose 2208 (15000 Mpa.s) - 17 mg/mL . The currest status of Visco Shield Lubricant drug is Active.
Drug Information:
| Drug NDC: | 42126-5200 |
| 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: | Visco Shield Lubricant |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Visco Shield |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Lubricant |
| 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: | Hypromellose 2208 (15000 Mpa.s) |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Oasis Medical, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Solution/ Drops |
| 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: | HYPROMELLOSE 2208 (15000 MPA.S) - 17 mg/mL
|
| 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: | 16 Jun, 2014 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 07 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: | 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: | OASIS Medical, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1540361
|
| 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: | 0342126520001
|
| UPC stands for Universal Product Code. |
| UNII: | Z78RG6M2N2
|
| 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 |
|---|
| 42126-5200-0 | 6 POUCH in 1 CARTON (42126-5200-0) / 1 SYRINGE, PLASTIC in 1 POUCH / 2 mL in 1 SYRINGE, PLASTIC | 16 Jun, 2014 | 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 ophthalmic lubricant
Product Elements:
Visco shield lubricant hypromellose 2208 (15000 mpa.s) hypromellose 2208 (15000 mpa.s) hypromellose 2208 (15000 mpa.s) calcium chloride magnesium chloride hydrochloric acid potassium chloride sodium acetate sodium chloride sodium citrate, unspecified form sodium hydroxide water
Indications and Usage:
Uses for the temporary relief of burning and irritation due to dryness of the eye for use as a lubricant to prevent further irritation or to relieve dryness of the eye
Warnings:
Warnings for external use only to avoid contamination do not touch tip of container or applicator to any surface once opened, discard do not reuse stop use and ask a doctor if you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours, discontinue use and consult a doctor if solution changes color or becomes cloudy, do not use keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.
Dosage and Administration:
Directions remove cap from syringe and screw on applicator tip instill 1 or 2 drops in the affected eye(s) as needed.
Stop Use:
Stop use and ask a doctor if you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours, discontinue use and consult a doctor if solution changes color or becomes cloudy, do not use
Package Label Principal Display Panel:
Principal display panel - 2 ml syringe carton visco shield ® topical drops ophthalmic lubricant drops sterile preservative-free single use, disposable container contains: 6 pouches, each pouch containing 1 single use syringe, 0.07 fl oz (2 ml) 1 single use applicator tip oasis ® oasis ® medical, glendora ca 91741 usa © 2014 oasis medical p940 3/2014 certain manufacturing operations have been performed by other firms principal display panel - 2 ml syringe carton
Further Questions:
Questions, or comments (800) 631-7180 or (909) 305-5400 or log onto www.oasistears.com