NDC 67751-198 Visine Red Eye Hydrating Comfort Eye Drops

Tetrahydrozoline Hydrochloride And Polyethylene Glycol 400

NDC Product Code 67751-198

NDC CODE: 67751-198

Proprietary Name: Visine Red Eye Hydrating Comfort Eye Drops 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: Tetrahydrozoline Hydrochloride And Polyethylene Glycol 400 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

  • 67751 - Navajo Manufacturing Company Inc.

NDC 67751-198-01

Package Description: 1 BOTTLE, DROPPER in 1 BLISTER PACK > 8 mL in 1 BOTTLE, DROPPER

NDC Product Information

Visine Red Eye Hydrating Comfort Eye Drops with NDC 67751-198 is a a human over the counter drug product labeled by Navajo Manufacturing Company Inc.. The generic name of Visine Red Eye Hydrating Comfort Eye Drops is tetrahydrozoline hydrochloride and polyethylene glycol 400. The product's dosage form is solution/ drops and is administered via ophthalmic form.

Labeler Name: Navajo Manufacturing Company 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 Red Eye Hydrating Comfort Eye Drops 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.

  • TETRAHYDROZOLINE HYDROCHLORIDE .5 mg/mL
  • POLYETHYLENE GLYCOL 400 10 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.

  • ASCORBIC ACID (UNII: PQ6CK8PD0R)
  • BORIC ACID (UNII: R57ZHV85D4)
  • DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • GLYCINE (UNII: TE7660XO1C)
  • HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
  • MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
  • POLIXETONIUM CHLORIDE (UNII: RNW5AM67C0)
  • POTASSIUM CHLORIDE (UNII: 660YQ98I10)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
  • SODIUM LACTATE (UNII: TU7HW0W0QT)
  • SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)

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: Navajo Manufacturing Company Inc.
Labeler Code: 67751
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: 06-01-2020 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: 12-31-2021 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 Red Eye Hydrating Comfort Eye Drops Product Label Images

Visine Red Eye Hydrating Comfort Eye Drops 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

Distributed by:
JOHNSON & JOHNSON CONSUMER INC. Skillman, NJ 08558

Otc - Purpose

Active ingredientsPurposePolyethylene 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, irritation, and discomfort due to dryness of the eye or exposure to wind or sunfor use as a protectant against further irritation or to relieve dryness of the eye

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

  • Adults and children 6 years of age and over: put 1 or 2 drops in the affected eye(s) up to 4 times a daychildren under 6 years of age: consult a doctorchildren under 2 years of age: do not use

Other Information

Store at 20° to 25°C (68° to 77°F)

Inactive Ingredients

Ascorbic acid, boric acid, dextrose, glycerin, glycine, hypromellose, magnesium chloride, polyquaternium-42, potassium chloride, purified water, sodium citrate, sodium lactate, sodium phosphate dibasic

Questions?

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

* Please review the disclaimer below.