Active Ingredient
Mineral Oil 42.5%
White Petrolatum 56.8%
Mineral Oil
FDA Label NDC 21695-681
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rebel Distributors Corp for the product Mineral Oil (NDC 21695-681). 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 active ingredient, purpose, keep out of reach of children, uses, warnings, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Eye lubricant
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Uses
For use as a protectant against further irritation or to relieve dryness or the eye.
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.
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
Use only if imprinted tape seals on top and bottom flaps are intact and clearly legible.
Store away from heat. Protect from freezing.
Use before expiration date marked on container.
RETAIN THIS CARTON FOR FUTURE REFERENCE.
Inactive Ingredients
Chlorobutanol and lanolin alcohols.
Package/Label Principal Display Panel
Lacri-lube (3f0ec253 6179 4609 8a67 00dbefc55033 01)
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