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

  • NDC Code(s): 83673-004-04
  • Packager: Renova Lifesciences Private Limited
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated August 1, 2024

If you are a consumer or patient please visit this version.

  • PROEYE LUBE EYE DROPS

    Active ingredientsPurpose
    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 Product LabelProeye 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

  • INGREDIENTS AND APPEARANCE
    PROEYE LUBE EYE DROPS 
    carboxymethylcellulose sodium 0.5 % solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83673-004
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) (CARBOXYMETHYLCELLULOSE - UNII:05JZI7B19X) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83673-004-041 in 1 CARTON08/01/2024
    110 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01808/01/2024
    Labeler - Renova Lifesciences Private Limited (873681128)
    Establishment
    NameAddressID/FEIBusiness Operations
    Renova Lifesciences Private Limited956992404manufacture(83673-004)