NDC 50269-300 Visine Advanced Blister 6s Pack

Dextran 70, Polyethylene Glycol 400, Povidone

NDC Product Code 50269-300

NDC CODE: 50269-300

Proprietary Name: Visine Advanced Blister 6s Pack What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Dextran 70, Polyethylene Glycol 400, Povidone What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 50269 - Jc World Bell Wholesale Co., Inc.

NDC 50269-300-08

Package Description: 6 BOTTLE in 1 BLISTER PACK > 8 mL in 1 BOTTLE

NDC Product Information

Visine Advanced Blister 6s Pack with NDC 50269-300 is a a human over the counter drug product labeled by Jc World Bell Wholesale Co., Inc.. The generic name of Visine Advanced Blister 6s Pack is dextran 70, polyethylene glycol 400, povidone. The product's dosage form is liquid and is administered via ophthalmic form.

Labeler Name: Jc World Bell Wholesale Co., Inc.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Visine Advanced Blister 6s Pack Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • DEXTRAN 70 1 mg/mL
  • POLYETHYLENE GLYCOL 400 10 mg/mL
  • POVIDONE 10 mg/mL
  • TETRAHYDROZOLINE HYDROCHLORIDE .5 mg/mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
  • BORIC ACID (UNII: R57ZHV85D4)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM BORATE (UNII: 91MBZ8H3QO)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Ophthalmic - Administration to the external eye.
  • Ophthalmic - Administration to the external eye.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Jc World Bell Wholesale Co., Inc.
Labeler Code: 50269
FDA Application Number: part349 What is the FDA Application Number?
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.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 09-30-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Visine Advanced Blister 6s Pack Product Label Images

Visine Advanced Blister 6s Pack Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredients

Dextran 70 0.1%Polyethylene glycol 400 1%Povidone 1%Tetrahydrozoline HCl 0.05%

Purpose

LubricantRedness reliever

Uses

  • For the relief of redness of the eye due to minor eye irritationsfor use as a protectant against further irritation or to relieve dryness of the eye

Warnings

For external use only

Ask A Doctor Before Use

If you have narrow angle glaucoma.

When Using This Product

  • Pupils may become enlarged temporarilyoveruse may cause more eye rednessremove contact lenses before usingreplace cap after each usedo not use if this solution changes color or becomes cloudydo not touch tip of container to any surface to avoid contamination

Stop Use And Ask A Doctor If

  • You feel eye painchanges in vision occurredness or irritation of the eye lastscondition worsens or lasts more than 72 hours

If Pregnant Or Breast-Feeding,

Ask a health professional before use.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Put 1 to 2 drops in the affected eye(s) up to 4 times dailychildren under 6 years of age: ask a doctor

Other Information

  • Store at 15° to 25°C (59° to 77°F)

Inactive Ingredients

Benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate, and sodium chloride

Questions?

Call toll-free 888-734-7648 or 215-273-8755 (collect)

* Please review the disclaimer below.