Otc - Active Ingredient
Light Mineral Oil 15%
White Petrolatum 83%
Lubrifresh Pm Ointment
FDA Label NDC 0904-7540
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Major Pharmaceuticals for the product Lubrifresh Pm (NDC 0904-7540). 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 otc - active ingredient, otc - purpose, indications & usage, dosage & administration, inactive ingredient, otc - keep out of reach of children, warnings, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Eye Lubricant
Indications & Usage
- 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
- wash your hands
- pull down the lower lid of the affected eye apply a small amount (1/4 inch) of ointment to the inside of eyelid, every 3-4 hours, or as directed by a doctor.
Inactive Ingredient
lanolin alcohols
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Warnings
For external use only
When using this product
- to avoid contamination do not touch tip of container to any surface
- replace cap after use
- you experience eye pain, changes in vision, continued redness or irritation of the eye
- condition worsens or persists for more than 72 hours
Stop use and ask a doctor if
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Package Label.Principal Display Panel
Lubrifresh Pm (Major Eolr)
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