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#
Contacts and useful links#
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
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0078-0473-97 | GM - Gram | 0078-0473 | eac2b0ba-3a3f-49ba-90ad-21980fc1d568 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Mineral Oil | ACTIVE INGREDIENT | T5L8T28FGP | 6 | |
| Petrolatum | ACTIVE INGREDIENT | 4T6H12BN9U | 6 | |
| Mineral Oil | ACTIVE MOIETY | T5L8T28FGP | 6 | |
| Petrolatum | ACTIVE MOIETY | 4T6H12BN9U | 6 |
Products#
Every source-derived product name is available through these pages.
- GenTeal Night-time PM
- white petrolatum
- Mineral Oil
- Petrolatum
- Lanolin
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0078-0473 | 0078-0473-97 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Mineral Oil | T5L8T28FGP | ACTIB |
| Petrolatum | 4T6H12BN9U | ACTIB |
| Lanolin | 7EV65EAW6H | IACT |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 77c70e52-63ce-45d9-ace8-1977c16a4b89 | 53d9aae9-bb12-48de-9cc5-a0060423ef37 | 2019-11-22 | Warnings | 77c70e52-63ce-45d9-ace8-1977c16a4b89 53d9aae9-bb12-48de-9cc5-a0060423ef37 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
