Drug Facts

Drug Facts
SPL v6
SPL
SPL Set ID 9d5998a7-4f59-4293-87da-8419650a524d
Route
OPHTHALMIC
Published
Effective Date 2024-12-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Mineral Oil (0.03 g) Petrolatum (0.94 g)
Inactive Ingredients
Lanolin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-09-05

Description

Active ingredients Purpose Mineral oil 3 % Lubricant White petrolatum 94 % Lubricant


Medication Information

Description

Active ingredients Purpose Mineral oil 3 % Lubricant White petrolatum 94 % Lubricant

Uses
  • for use as a lubricant to prevent further irritation
  • to relieve dryness of the eye.
Section 50566-9

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
Section 55105-1
Active ingredients Purpose
Mineral oil 3 % Lubricant
White petrolatum 94 % Lubricant
Warnings

For external use only

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.

Do Not Use
  • if you are sensitive to any ingredient in this product
Questions?

In the U.S., call toll-free 1-800-757-9195

(Mon-Fri 9AM-5PM CST)

[email protected]

Other Information

store at 8° – 27° C (46° – 80° F).

Inactive Ingredient:

Anhydrous liquid lanolin

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, do not use if carton security seal is damaged or missing at the time of purchase.



Distributed by:

ALCON LABORATORIES, INC.,

6201 South Freeway

Fort Worth, Texas 76134 USA

Country of Origin: Belgium



1635962-0723



LOT:

EXP.:



Please read this carton carefully and keep for future reference.

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, do not use if carton security seal is damaged or missing at the time of purchase.



Distributed by:

ALCON LABORATORIES, INC.,

6201 South Freeway

Fort Worth, Texas 76134 USA

Country of Origin: Spain



3601067 01-0724

When Using This Product
  • do not touch tip of container to any surface
  • replace cap after using
Keep Out of Reach of Children

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


Structured Label Content

Uses
  • for use as a lubricant to prevent further irritation
  • to relieve dryness of the eye.
Section 50566-9 (50566-9)

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
Section 55105-1 (55105-1)
Active ingredients Purpose
Mineral oil 3 % Lubricant
White petrolatum 94 % Lubricant
Warnings

For external use only

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.

Do Not Use (Do not use)
  • if you are sensitive to any ingredient in this product
Questions?

In the U.S., call toll-free 1-800-757-9195

(Mon-Fri 9AM-5PM CST)

[email protected]

Other Information (Other information)

store at 8° – 27° C (46° – 80° F).

Inactive Ingredient: (Inactive ingredient:)

Anhydrous liquid lanolin

Principal Display Panel (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, do not use if carton security seal is damaged or missing at the time of purchase.



Distributed by:

ALCON LABORATORIES, INC.,

6201 South Freeway

Fort Worth, Texas 76134 USA

Country of Origin: Belgium



1635962-0723



LOT:

EXP.:



Please read this carton carefully and keep for future reference.

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, do not use if carton security seal is damaged or missing at the time of purchase.



Distributed by:

ALCON LABORATORIES, INC.,

6201 South Freeway

Fort Worth, Texas 76134 USA

Country of Origin: Spain



3601067 01-0724

When Using This Product (When using this product)
  • do not touch tip of container to any surface
  • replace cap after using
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.


Advanced Ingredient Data


Raw Label Data

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