Otc - Purpose
Eye Lubricant
Equate Nighttime Relief Lubricant Ointment
FDA Label NDC 11716-0367
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Hanlim Pharm Co. Ltd for the product Equate Nighttime Relief Lubricant (NDC 11716-0367). 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 - purpose, otc - keep out of reach of children, warnings, otc - active ingredient, inactive ingredient, dosage & administration, other safety information, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
WARNING
For External Use Only
Do not use
■ except under the advice and supervision of a doctor
When using this product
■replace cap after use to avoid contamination
■do not touch tip of container to any surface remove contact lenses before using
Stop use and ask a doctor if
■ you experience eye pain, changes in vision, continued redness or irritation of the eye
condition worsens or persists for more than 72 hours
Otc - Active Ingredient
Active ingredients
Light Mineral Oil 42.5%
White Petrolatum 57.3%
Inactive Ingredient
Inactive Ingredients
Lanolin alcohols
Dosage & Administration
Directions:
pull down the lower lid of the affected eye
apply a small amount (1/4 inch) of ointment to the inside of eyelid
Other Safety Information
Other information
■ Store at 15-25°C (59-77 °F)
■ DO NOT FREEZE
■ keep tightly closed
■ do not use if difficult to dispense or visible particles are seen in the product
■ do not roll, bend, twist, or fold tube during use
■ store away from heat
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
* Please review the disclaimer below.
