PROEYE LUBE EYE DROPS- carboxymethylcellulose sodium 0.5 % solution/ drops

PROEYE LUBE EYE DROPS by

Drug Labeling and Warnings

PROEYE LUBE EYE DROPS by is a Otc medication manufactured, distributed, or labeled by Renova Lifesciences Private Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PROEYE LUBE EYE DROPS

• Active ingredients: Purpose
• Carboxymethylcellulose Sodium 0.5 %: Lubricant

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.

WARNINGS

• 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

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

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

DIRECTIONS

• 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

Store at room temperature

INACTIVE INGREDIENTS:

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?

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

www.proeye.in

DOSAGE & ADMINISTRATION

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

PURPOSE

• 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.

PRINCIPAL DISPLAY PANEL

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

INGREDIENTS AND APPEARANCE

PROEYE LUBE EYE DROPS 
carboxymethylcellulose sodium 0.5 % solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83673-004
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) (CARBOXYMETHYLCELLULOSE - UNII:05JZI7B19X)	CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM	5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM CHLORATE (UNII: T95DR77GMR)
SODIUM CHLORITE (UNII: G538EBV4VF)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)
BORIC ACID (UNII: R57ZHV85D4)
GLYCERIN (UNII: PDC6A3C0OX)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
CHLORINE DIOXIDE (UNII: 8061YMS4RM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83673-004-04	1 in 1 CARTON	08/01/2024
1		10 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M018	08/01/2024

Labeler - Renova Lifesciences Private Limited (873681128)

Establishment
Name	Address	ID/FEI	Business Operations
Renova Lifesciences Private Limited		956992404	manufacture(83673-004)