Drugplain

REFRESH LACRI-LUBE 425 mg/g

mineral oil, petrolatum · OINTMENT · Allergan, Inc.

2 Recalls on Record
Plain English

REFRESH LACRI-LUBE is a ointment containing mineral oil, petrolatum at 425 mg/g, taken ophthalmic. Manufactured by Allergan, Inc..

Key Facts

Brand Name
REFRESH LACRI-LUBE
Generic Name
mineral oil, petrolatum
NDC Code (Product)
0023-0312
Manufacturer
Allergan, Inc.
Strength
425 mg/g
Dosage Form
OINTMENT
Route
OPHTHALMIC
Marketing Status
Application #
M018
Marketing Start
12/15/1977

Recall History

2 Recalls on Record
Class II08/24/2015

Allergan Sales, LLC

Presence of Particulate Matter: Due to customer complaints of small black particles, identified as part of the ointment tube cap, generated by the action of unscrewing the cap from the aluminum tube and potentially introducing the particle into the product.

TerminatedVoluntary: Firm initiated
Class II09/16/2024

AbbVie Inc.

Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.

OngoingVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

eye pain32 reports
eye irritation21 reports
vision blurred13 reports
ocular hyperaemia10 reports
drug ineffective9 reports
lacrimation increased9 reports
off label use9 reports
product dose omission issue9 reports
dry eye8 reports
eye swelling8 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & 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 & Administration

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.

Warnings

Warnings For external use only. To avoid contamination, do not touch tip of container to any surface. Replace cap after using. 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.

Frequently Asked Questions

What is REFRESH LACRI-LUBE used for?

REFRESH LACRI-LUBE contains mineral oil, petrolatum. It is a ointment taken ophthalmic. Consult your doctor for specific uses.

Is REFRESH LACRI-LUBE a controlled substance?

REFRESH LACRI-LUBE is not classified as a controlled substance by the DEA.

What is the generic name for REFRESH LACRI-LUBE?

The generic name for REFRESH LACRI-LUBE is mineral oil, petrolatum. There are 11 other brand versions of mineral oil, petrolatum.

What is the NDC code for REFRESH LACRI-LUBE 425 mg/g?

The NDC (National Drug Code) for REFRESH LACRI-LUBE 425 mg/g is 0023-0312, listed by Allergan, Inc..

Product NDC

0023-0312

Package NDC

0023-0312-04

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)