Genteal Ointment
FDA Label NDC 0065-0518

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Alcon Laboratories, Inc. for the product Genteal (NDC 0065-0518). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - purpose, uses, warnings, do not use, when using this product, otc - stop use, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Purpose

Active ingredientsPurpose
Mineral oil 3 %Lubricant
White petrolatum 94 %Lubricant

Uses

  • for use as a lubricant to prevent further irritation
  • to relieve dryness of the eye.

Warnings

For external use only

Do Not Use

  • if you are sensitive to any ingredient in this product

When Using This Product

  • do not touch tip of container to any surface
  • replace cap after using

Otc - Stop Use

Stop use and ask a doctor if you experience any of the following:

  • eye pain
  • changes in vision
  • continued redness or irritation of the eye
  • condition worsens or 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.

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.

Other Information

store at 8° – 27° C (46° – 80° F).

Inactive Ingredient:

Anhydrous liquid lanolin

Questions?

In the U.S., call toll-free 1-800-757-9195
(Mon-Fri 9AM-5PM CST)
[email protected]

Principal Display Panel

Severe
DRY EYE SYMPTOM RELIEF 

OINTMENT

GenTeal®
Tears

LUBRICANT EYE OINTMENT

GenTeal® Night-time PM ointment provides long-lasting relief for night-time comfort.

NIGHT-TIME OINTMENT
Long-lasting Night-time Relief

STERILE 3.5 g (0.12 FL OZ)

Alcon®

TAMPER EVIDENT:
For your protection, use only if cap and necking are intact at time of purchase.

Distributed by:
ALCON LABORATORIES, INC.,
6201 South Freeway
Fort Worth, Texas 76134 USA
Country of Origin: Belgium

787130-1218

LOT:
EXP.:

Please read this carton carefully and keep for future reference.

Carton (Label)

Carton (Label)

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