Otc - Purpose
Purpose: Lubricant
Equate Lubricant Eye Drops Solution/ Drops
FDA Label NDC 11716-0364
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 for the product Equate Lubricant Eye Drops (NDC 11716-0364). 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, dosage & administration, warnings, otc - keep out of reach of children, otc - active ingredient, indications & usage, inactive ingredient, 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
Dosage & Administration
Directions:
instill 1 to2 drops in the affected eye(s) as needed
Warnings
Warnings
For external use only
Do not use
■ If thisproduct changes color or becomes cloudy
■ if you are sensitive to any ingredient in this product
When using this product
■ 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 to the
condition worsens or persists for more than 72 hours
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.
Otc - Active Ingredient
Active ingredient
Carboxymethylcellulose sodium 0.5%.
Indications & Usage
Uses
■ for the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun
■ maybe used as a protectant against further irritation
Inactive Ingredient
Inactive ingredients
benzalkonium chloride,boric acid, calcium chloride hydrate (dihydrate), hydrochloric acid**, magnesium chloride, potassium chloride, sodium borate, sodium chloride, sodium hydroxide**, water for injection **may contain hydrochloric acid and sodium hydroxide to adjust pH
* Please review the disclaimer below.
