FDA.reportPublic FDA data

PROEYE LUBE EYE DROPS

Manufacturer
Renova Lifesciences Private Limited
Effective date
2024-08-01
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 20:57:22

Label at a glance#

ProductPROEYE LUBE EYE DROPS
Active ingredientCARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
Label structure12 sections

Indications and uses

For the temporary relief of burning, irritation and discomfort due to dryness of the eye or due to exposure to wind or sun. May be used as a protectant against further irritation.

Dosage and administration

Instill 1 or 2 drops in the affected eye(s) as needed. Use the solution within 1 month of opening the vial. Use before expiration date marked on container. RETAIN THIS CARTON FOR FUTURE REFERENCE.

Storage and handling

Store at room temperature

Label contents#

Full prescribing information#

PROEYE LUBE EYE DROPS

OTC - ACTIVE INGREDIENT SECTION

Active ingredientsPurpose
Carboxymethylcellulose Sodium 0.5 %Lubricant

Uses

INDICATIONS & USAGE SECTION

  • For the temporary relief of burning, irritation and discomfort due to dryness of the eye or due to exposure to wind or sun.
  • May be used as a protectant against further irritation.

WARNINGS

WARNINGS SECTION

  • For external use only.
  • To avoid contamination, do not touch tip of container to any surface. Replace cap after using.
  • If solution changes color or becomes cloudy, do not use.

STOP USE

OTC - STOP USE SECTION

Stop use and ask a doctorif 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.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

INSTRUCTIONS FOR USE SECTION

  • Instill 1 or 2 drops in the affected eye(s) as needed.
  • Use the solution within 1 month of opening the vial.
  • Use before expiration date marked on container.
  • RETAIN THIS CARTON FOR FUTURE REFERENCE.

STORAGE

STORAGE AND HANDLING SECTION

Store at room temperature

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Oxychloro Complex (As preservative), Glycerin, Calcium Chloride Dihydrate, Magnesium Chloride Hexahydrate, Boric Acid, Sodium Chloride, Potassium Chloride, Sodium hydroxide (to adjust pH), Purified Water.

QUESTIONS?

OTC - QUESTIONS SECTION

In the U.S. call toll-free 1-888-589-6879 (Mon-Fri 9AM-5PM MST)
info@proeye.in

www.proeye.in

DOSAGE & ADMINISTRATION SECTION

  • Instill 1 or 2 drops in the affected eye(s) as needed.

OTC - PURPOSE SECTION

  • For the temporary relief of burning, irritation and discomfort due to dryness of the eye or due to exposure to wind or sun.
  • May be used as a protectant against further irritation.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Proeye Lube Product LabelProeye Lube Product LabelProeye Lube CartonProeye Lube Carton

PROEYE LUBE Carton

PROEYE LUBE Product Label


LUBRICANT EYE DROPS

Immediate, soothing relief for dry eyes

Lubricant Eye Drops instantly moisturizes and relieves dry, irritated eyes with a fast-acting, long-lasting formula that has many of the same healthy qualities as your own natural tears.


STERILE

One 10 mL Bottle (0.34 FL OZ)


RENOVA LIFESCIENCES PRIVATE LIMITED

Plot No: 35/36/37, R. K. Industrial Park, Phase - 1, Opp. Bharat Benz Showroom

Off. Rajkot-Ahmedabad N.H. 8-B, Rampara- 360023

Dist - Rajkot, Gujarat - INDIA

TM - Trade Mark Applied for Proeye Lube

Questions?:In the U.S. call toll-free (888) 589-6879

(Mon-Fri 9AM-5PM MST)

info@proeye.in

www.proeye.in

FOR EXTERNAL USE ONLY

Uses:See carton for USES

WARNINGS:See carton for WARNINGS

PROEYE LUBE

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83673-00483673-004-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM CHLORATET95DR77GMRIACT
SODIUM CHLORITEG538EBV4VFIACT
SODIUM HYDROXIDE55X04QC32IIACT
POTASSIUM CHLORIDE660YQ98I10IACT
CALCIUM CHLORIDEM4I0D6VV5MIACT
BORIC ACIDR57ZHV85D4IACT
GLYCERINPDC6A3C0OXIACT
MAGNESIUM CHLORIDE02F3473H9OIACT
WATER059QF0KO0RIACT
SODIUM CHLORIDE451W47IQ8XIACT
CHLORINE DIOXIDE8061YMS4RMIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
33e3e756-b53d-ed19-e063-6294a90aa895032b333e-17b6-e079-e063-6394a90aff472025-04-29WarningsExact identifier
spl set id: 032b333e-17b6-e079-e063-6394a90aff47

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.