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SPL v7
SPL
SPL Set ID d232a44b-516d-4cdf-a4e7-c3a9a50dc7af
Route
ophthalmic
Published
Effective Date 2022-12-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
mineral oil (425 mg) petrolatum (568 mg)
Inactive Ingredients
chlorobutanol lanolin alcohols

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 1977-12-15

Purpose

Eye lubricant Eye lubricant

Description

Mineral Oil 42.5% White Petrolatum 56.8%


Medication Information

Warnings
  • For external use only.

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

  • Replace cap after using.
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

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.
Inactive Ingredients

Chlorobutanol and Lanolin alcohols.

Description

Mineral Oil 42.5% White Petrolatum 56.8%

Principal Display Panel

NDC 0023-0312-04

Lubricant Eye Ointment

Refresh ®

L ACRI -L UBE ®

Nighttime Relief for

Intense Eye Dryness

Net wt. 0.12 oz (3.5 g) Sterile

Active Ingredients

Mineral Oil 42.5%

White Petrolatum 56.8%

Questions Or Comments?

1.800.678.1605

refreshbrand.com

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

Warnings
  • For external use only.

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

  • Replace cap after using.
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

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.
Inactive Ingredients (Inactive ingredients)

Chlorobutanol and Lanolin alcohols.

Principal Display Panel

NDC 0023-0312-04

Lubricant Eye Ointment

Refresh ®

L ACRI -L UBE ®

Nighttime Relief for

Intense Eye Dryness

Net wt. 0.12 oz (3.5 g) Sterile

Active Ingredients (Active ingredients)

Mineral Oil 42.5%

White Petrolatum 56.8%

Questions Or Comments? (Questions or comments?)

1.800.678.1605

refreshbrand.com

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

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