GenTeal

Manufacturer
Novartis Pharmaceutical Corporation | S.A. Alcon-Couvreur N.V.
Effective date
2019-11-22
Label type
HUMAN OTC DRUG LABEL
Version
12
Source
legacy-cache
Hydrated at
2026-08-01 23:57:40

Label at a glance#

ProductGenTeal Night-time PM
Active ingredientMineral Oil, Petrolatum
Label structure13 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Mineral oil (15%)
White petrolatum (85%)

OTC - PURPOSE SECTION

Lubricant

INDICATIONS & USAGE SECTION

  • Relieves dryness of the eye.
  • Temporarily relieves discomfort due to minor irritations of the eye or from exposure to wind or sun.
  • As a protectant against further irritation.

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

  • if you are sensitive to any ingredient in this product

OTC - WHEN USING SECTION

When using this product do not touch tip of container to any surface. Replace cap after using.

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

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 SAFETY INFORMATION

Store between 15°- 25°C (59°-77°F).

INACTIVE INGREDIENT SECTION

anhydrous liquid lanolin

OTC - QUESTIONS SECTION

In the U.S. call toll-free 1-866-393-6336; MedInfo@AlconLabs.com
Serious side effects associated with use of this product may be reported to this telephone number.
www.genteal.com

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0078-0473-97

Night-time PM
Dry Eye Relief

GenTeal ®
LUBRICANT EYE OINTMENT

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

NIGHT-TIME OINTMENT
Long-lasting Night-time Relief

Alcon®

STERILE 3.5 g (0.12 fl oz)

Carton
Carton

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0078-0473-97GM - Gram0078-0473eac2b0ba-3a3f-49ba-90ad-21980fc1d56812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Mineral OilACTIVE INGREDIENTT5L8T28FGP6
PetrolatumACTIVE INGREDIENT4T6H12BN9U6
Mineral OilACTIVE MOIETYT5L8T28FGP6
PetrolatumACTIVE MOIETY4T6H12BN9U6

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0078-04730078-0473-97

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
Mineral OilT5L8T28FGPACTIB
Petrolatum4T6H12BN9UACTIB
Lanolin7EV65EAW6HIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
77c70e52-63ce-45d9-ace8-1977c16a4b8953d9aae9-bb12-48de-9cc5-a0060423ef372019-11-22WarningsExact identifier
spl id: 77c70e52-63ce-45d9-ace8-1977c16a4b89
spl set id: 53d9aae9-bb12-48de-9cc5-a0060423ef37

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.