Active Ingredient
Hypromellose
Natures Tears
FDA Label NDC 21695-930
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 Natures Tears (NDC 21695-930). 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
Lubricant
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Uses
° relieves dryness of the eye
° prevents further irritation
Warnings
Do not use if solution changes color or becomes cloudy
When using this product:
° do not touch tip of container to any surface to avoid contamination
° replace cap after use
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
Directions
° instill 1 or 2 drops in the affected eye(s) as needed
Other Information
° store at 15° - 30°C (59° - 85°F)
° keep tightly closed
FOR USE IN THE EYES ONLY
Inactive Ingredients
dibasic sodium phosphate, edetate disodium, monobasic sodium phosphate,
potassium chloride, sodium chloride, purified water.
Hydrochloric acid and/or sodium hydroxide may be added to adjust pH.
Preservative added: benzalkonium chloride 0.01%
Questions Of Comments?
Call 1-800-645-2158
9 am - 5 pm ET, Monday-Friday.
Serious side effects associated with use of this product may be reported to this number.
Distributed by:
Rugby Laboratories, Inc.
Duluth, GA 30097
Repackaged by:
Rebel Distributors Corp.
Thousand Oaks, CA 91320
Package/Label Principal Display Panel
Nature's Tears 0.4% (785199ea 3bd6 48ea Afd0 E0c4cf39652b 01)
* Please review the disclaimer below.
