Lubricant Pm Eye
FDA Label NDC 42494-461

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cameron Pharmaceuticals for the product Lubricant Pm Eye (NDC 42494-461). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, use, warnings, when using this product, stop use and ask a doctor if, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Other

→ Active Ingredient

→ Purpose

→ Use

→ Warnings

→ When Using This Product

→ Stop Use And Ask A Doctor If

→ Otc - Pregnancy Or Breast Feeding

→ Otc - Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions Or Comments?

→ Principal Display Panel - 3.5 G Bottle Carton

Other

Drug Facts

Distributed by: Cameron Pharmaceuticals, LLC
Louisville, KY 40245

Active Ingredient

Mineral Oil 42.5% and White Petrolatum 57.3%

Purpose

Eye Lubricant

Use

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 use in the eyes only

Retain outer carton for full product drug facts.

When Using This Product

Avoid contamination, do not touch tip of container to any surface.
Replace cap after use.

Stop Use And Ask A Doctor If

You experience eye pain, changes in vision, continued redness or irritationn of the eye.
Condition worsens or persists for more than 72 hours.

Otc - Pregnancy Or Breast Feeding

If pregnant or breastfeeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

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

Directions

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