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SPL v8
SPL
SPL Set ID 24365d64-cd94-41cc-a7e1-033102d98114
Route
OPHTHALMIC
Published
Effective Date 2022-06-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2016-08-26 Until 2019-04-17
Description

Mineral Oil 42.5% White Petrolatum 57.3%

Purpose

Eye lubricant Eye lubricant

Medication Information

Purpose

Eye lubricant

Eye lubricant

Description

Mineral Oil 42.5% White Petrolatum 57.3%

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.
Warnings
  • For external use only.

  • To avoid contamination, do not touch tip of container to any surface.

  • Replace cap after using.
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.

Other Information
  • Store away from heat.

  • Protect from freezing.

  • Use only if tape seals on top and bottom flaps are intact.

  • Use before expiration date marked on container.

  • Store at 59°-77°F (15°-25°C).

  • RETAIN THIS CARTON FOR FUTURE REFERENCE.
Active Ingredients

Mineral Oil 42.5%

White Petrolatum 57.3%

Inactive Ingredients

Lanolin alcohols.

Questions Or Comments?

1.800.678.1605

refreshbrand.com

v1.0DFL0667

Principal Display Panel

NDC 0023-0667-04

PRESERVE-FREE

Lubricant Eye Ointment

For Eye Dryness

Refresh

P.M. ®

Nighttime Relief for

Intense Eye Dryness

Net wt. 0.12 oz (3.5 g) Sterile

Stop Use and Ask A Doctor If

you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours.

Keep Out of Reach of Children.

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

Structured Label Content

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.
Purpose

Eye lubricant

Eye lubricant

Warnings
  • For external use only.

  • To avoid contamination, do not touch tip of container to any surface.

  • Replace cap after using.
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.

Other Information (Other information)
  • Store away from heat.

  • Protect from freezing.

  • Use only if tape seals on top and bottom flaps are intact.

  • Use before expiration date marked on container.

  • Store at 59°-77°F (15°-25°C).

  • RETAIN THIS CARTON FOR FUTURE REFERENCE.
Active Ingredients (Active ingredients)

Mineral Oil 42.5%

White Petrolatum 57.3%

Inactive Ingredients (Inactive ingredients)

Lanolin alcohols.

Questions Or Comments? (Questions or comments?)

1.800.678.1605

refreshbrand.com

v1.0DFL0667

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 0023-0667-04

PRESERVE-FREE

Lubricant Eye Ointment

For Eye Dryness

Refresh

P.M. ®

Nighttime Relief for

Intense Eye Dryness

Net wt. 0.12 oz (3.5 g) Sterile

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours.

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

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:43.475716 · Updated: 2026-03-14T23:02:25.522673