Grandall (as PLD) - Oftal-Mycin Lubricant Ophthalmic Ointment (48201-301)

Manufacturer: GRANDALL DISTRIBUTING, LLC
Effective date: 2025-10-27
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-06-01 01:41:11

Label at a glance#

ProductOFTAL-MYCIN LUBRICANT OPHTHALMIC

Active ingredientWHITE PETROLATUM, LIGHT MINERAL OIL

Label structure10 sections

Indications and uses

for the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun may be used as a protectant against further irritation

Dosage and administration

wash your hands pull down the lower lid of the affected eye and gently apply a small amount (1/4 inch) of ointment to the inside of eyelid, every 3-4 hours or as directed by a doctor

Storage and handling

store away from heat protect from freezing use before expiration date on the tube store at 15-25°C (59-77°F)

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1800-344-2422

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Light Mineral Oil 15%

White Petrolatum 83%

PURPOSE

OTC - PURPOSE SECTION

EYE LUBRICANT

USES

INDICATIONS & USAGE SECTION

for the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun
may be used as a protectant against further irritation

WARNINGS

WARNINGS SECTION

For external use only

When using this product

to avoid contamination do not touch tip of container to any surface
keep tube tightly closed

Stop use and ask a doctor if

you experience 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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

wash your hands
pull down the lower lid of the affected eye and gently apply a small amount (1/4 inch) of ointment to the inside of eyelid, every 3-4 hours or as directed by a doctor

OTHER INFORMATION

STORAGE AND HANDLING SECTION

store away from heat
protect from freezing
use before expiration date on the tube
store at 15-25°C (59-77°F)

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

LANOLIN ALCOHOLS

QUESTIONS OR COMMENTS?

OTC - QUESTIONS SECTION

CALL 1800-344-2422

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
746083	mineral oil 15 % / petrolatum 83 % Ophthalmic Ointment	PSN	4
746083	mineral oil 0.15 MG/MG / petrolatum 0.83 MG/MG Ophthalmic Ointment	SCD	4
746083	mineral oil 15 % / petrolatum, white 83 % Ophthalmic Ointment	SY	4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
48201-301-11	OFTAL-MYCIN LUBRICANT OPHTHALMIC	3.5 g in 1 BOTTLE	OINTMENT	3.5		4

Products#

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

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

OFTAL-MYCIN LUBRICANT OPHTHALMIC
LIGHT MINERAL, WHITE PETROLATUM
WHITE PETROLATUM
LIGHT MINERAL OIL
LANOLIN ALCOHOLS

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
48201-301	48201-301-11

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
Name	UNII	Kind
WHITE PETROLATUM	B6E5W8RQJ4	ACTIB
LIGHT MINERAL OIL	N6K5787QVP	ACTIB
LANOLIN ALCOHOLS	884C3FA9HE	IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
3	2025-08-01	full-release	2026-06-01 01:09:53

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
OFTAL-MYCIN LUBRICANT OPHTHALMIC	LIGHT MINERAL, WHITE PETROLATUM	GRANDALL DISTRIBUTING, LLC	298db04a-21a9-e46e-e063-6294a90acee2	2025-10-27	Warnings	Exact identifier ndc (package): 48201-301-11 ndc (product): 48201-301 ndc11 (package): 48201030111 spl id: 422c0915-37ab-dfd4-e063-6294a90ac5d3 spl set id: 298db04a-21a9-e46e-e063-6294a90acee2

Reported adverse events (FAERS/openFDA)#

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