Label: GNP LUBRICATING RELIEF- carboxymethylcellulose sodium solution/ drops

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated October 1, 2019

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  • ACTIVE INGREDIENT

    Active ingredient                                         Purpose

    Carboxymethylcellulose Sodium 0.5%...........Eye lubricant

  • PURPOSE

    Uses

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

    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 doctor if 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.
  • INDICATIONS & USAGE

    Directions

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

    Other information

    •
    Use before expiration date marked on container.
    •
    Store at 59°-86°F (15°-30°C).
    •
    RETAIN THIS CARTON FOR FUTURE REFERENCE.
  • INACTIVE INGREDIENT

    Inactive ingredients

    benzalkonium chloride, boric acid, calcium chloride, hydrochloric acid, magnesium chloride, potassium chloride, purified water, sodium borate, sodium chloride, sodium hydroxide

  • DOSAGE & ADMINISTRATION

    Distributed by

    AmerisourceBergen

    1300 Morris Drive

    Chesterbrook, PA 19087

    Questions or Concerns?

    www.mygnp.com

    Relabeled By;

    Proficient Rx LP

    Thousand Oaks CA 91320

    Made in Korea

  • PRINCIPAL DISPLAY PANEL

    71205-084-15
  • INGREDIENTS AND APPEARANCE
    GNP LUBRICATING RELIEF 
    carboxymethylcellulose sodium solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71205-084(NDC:46122-377)
    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
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    BORIC ACID (UNII: R57ZHV85D4)  
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71205-084-151 in 1 BOX08/01/2018
    115 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 finalpart34909/30/2016
    Labeler - Proficient Rx LP (079196022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Proficient Rx LP079196022RELABEL(71205-084)
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