NDC 42002-211 Visine Maximum Strength Redness Relief Formula

Glycerin, Hypromelloses, Polyethylene Glycol 400, And Tetrahydrozoline Hydrochloride

NDC Product Code 42002-211

NDC CODE: 42002-211

Proprietary Name: Visine Maximum Strength Redness Relief Formula 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: Glycerin, Hypromelloses, Polyethylene Glycol 400, And Tetrahydrozoline Hydrochloride 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This product is used to relieve occasional constipation. Glycerin belongs to a class of drugs known as hyperosmotic laxatives. It works by drawing water into the intestines. This effect usually results in a bowel movement within 15 to 60 minutes. For adults, the normal frequency of bowel movements varies from once daily to 1 to 2 times weekly. For preschool-aged children, the normal frequency of bowel movements varies from once daily to once every other day. Constipation is best treated by drinking plenty of fluids, eating foods high in fiber, and exercising regularly.

NDC Code Structure

  • 42002 - Johnson & Johnson Consumer Inc.
    • 42002-211 - Visine Maximum Strength Redness Relief Formula

NDC 42002-211-05

Package Description: 1 BOTTLE, DROPPER in 1 CARTON > 15 mL in 1 BOTTLE, DROPPER

NDC Product Information

Visine Maximum Strength Redness Relief Formula with NDC 42002-211 is a a human over the counter drug product labeled by Johnson & Johnson Consumer Inc.. The generic name of Visine Maximum Strength Redness Relief Formula is glycerin, hypromelloses, polyethylene glycol 400, and tetrahydrozoline hydrochloride. The product's dosage form is solution/ drops and is administered via ophthalmic form.

Labeler Name: Johnson & Johnson Consumer Inc.

Dosage Form: Solution/ Drops - A solution which is usually administered in a drop-wise fashion.

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 Maximum Strength Redness Relief Formula 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.

  • GLYCERIN 2 mg/mL
  • HYPROMELLOSE, UNSPECIFIED 3.6 mg/mL
  • POLYETHYLENE GLYCOL 400 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 CHLORIDE (UNII: 451W47IQ8X)
  • SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)

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.

Product Labeler Information

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

Labeler Name: Johnson & Johnson Consumer Inc.
Labeler Code: 42002
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: 06-29-2011 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

End Marketing Date: 08-31-2021 What is the End Marketing Date?
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.

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 Maximum Strength Redness Relief Formula Product Label Images

Visine Maximum Strength Redness Relief Formula 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

Other

Drug Facts

Otc - Purpose

Active ingredientsPurposeGlycerin 0.2%LubricantHypromellose 0.36%LubricantPolyethylene glycol 400 1%LubricantTetrahydrozoline HCl 0.05%.Redness reliever

Uses

  • For the relief of redness of the eye due to minor eye irritationsfor the temporary relief of burning and discomfort due to dryness of the eye or exposure to wind or sunfor protection against further irritation

Warnings

For external use only

Otc - Ask Doctor

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 usingdo not use if this solution changes color or becomes cloudydo not touch tip of container to any surface to avoid contaminationreplace cap after each use

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

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

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

Other Information

  • Store at 20° to 25° C (68° to 77° F)

Inactive Ingredients

Benzalkonium chloride, boric acid, edetate disodium, purified water, sodium chloride, sodium citrate

Questions?

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

* Please review the disclaimer below.