SPL v2
SPL
SPL Set ID 4449a55b-2cd4-0cb9-e063-6294a90aafbc
Route
OPHTHALMIC
Published
Effective Date 2025-12-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Light Mineral Oil (425 mg) White Petrolatum (573 mg)
Inactive Ingredients
Lanolin Alcohols

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-26
Description

Eye Lubricant

Medication Information

Warnings and Precautions

WARNING

For External Use Only

Do not use

■ except under the advice and supervision of a doctor

When using this product

■replace cap after use to avoid contamination

■do not touch tip of container to any surface remove contact lenses before using

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

Indications and Usage

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

Directions:

pull down the lower lid of the affected eye

apply a small amount (1/4 inch) of ointment to the inside of eyelid

Description

Eye Lubricant

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center

(1-800-222-1222) right away.

Section 51727-6

Inactive Ingredients

Lanolin alcohols

Section 51945-4

Section 55105-1

Eye Lubricant

Section 55106-9

Active ingredients

Light Mineral Oil 42.5%

White Petrolatum 57.3%

Section 60561-8

Other information

■ Store at 15-25°C (59-77 °F)

■ DO NOT FREEZE

■ keep tightly closed

■ do not use if difficult to dispense or visible particles are seen in the product

■ do not roll, bend, twist, or fold tube during use

■ store away from heat

Structured Label Content

Indications and Usage (34067-9)

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 (34068-7)

Directions:

pull down the lower lid of the affected eye

apply a small amount (1/4 inch) of ointment to the inside of eyelid

Warnings and Precautions (34071-1)

WARNING

For External Use Only

Do not use

■ except under the advice and supervision of a doctor

When using this product

■replace cap after use to avoid contamination

■do not touch tip of container to any surface remove contact lenses before using

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

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center

(1-800-222-1222) right away.

Section 51727-6 (51727-6)

Inactive Ingredients

Lanolin alcohols

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Eye Lubricant

Section 55106-9 (55106-9)

Active ingredients

Light Mineral Oil 42.5%

White Petrolatum 57.3%

Section 60561-8 (60561-8)

Other information

■ Store at 15-25°C (59-77 °F)

■ DO NOT FREEZE

■ keep tightly closed

■ do not use if difficult to dispense or visible particles are seen in the product

■ do not roll, bend, twist, or fold tube during use

■ store away from heat

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:54.918515 · Updated: 2026-03-14T23:11:54.825001