Label: CARBOXYMETHYLCELLULOSE SODIUM EYE DROPS 0.5% for solution

  • 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 August 23, 2023

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • Active ingredient

    Carboxymethyl cellulose sodium Eye Drops 0.5% w/v

  • DIRECTIONS FOR USE

    • lnstill 1or 2 drops in the affected eye, as needed
  • INACTIVE INGREDIENT

    1.Boric acid

    2.Calcium chloride

    3.Glycerin
    4.Magnesium chloride

    5.Mannitol

    6.Potassium chloride

    7.Purified water

    8.Stablized oxy cholro complex

    9.Sodium tetra borate
    10.Sodium hyaluronate

    11.Sodium citrate

  • Tamper Protection

    • For your protection a tamper evident ring is attached to the bottlecap
    • Upon opening, this will separate from the cap and can be discarded
    • Use only if this ring is present and attached when the bottle is first opened
  • Use

    For use as a lubricant to prevent further irritation or to relieve dryness of the eye

  • Questions

    Call. 1-800-103-7321
    E-mail : info@aurolab.com
    Web : www.aurolab.com

  • Keep out of reach of children

    If swallowed get medical help or contact a Poison Control Center right away

  • Stop use and ask a doctor if

    1.Excessive watering of the eye

    2.Burning, stinging,foreign body sensation Continued redness (or) irritation of the eye, unusual eye secretions, change in vision

  • Do not use

    1.If you are sensitive to any ingredient in this product
    2.If solution changes color or becomes cloudy

  • Warnings

    For external use only

  • Indication & usage

    Do not touch the nozzle tip to any surface since this may contaminate the solution
    Remove contact lenses before use Should not use at the same time as other ophthalmic drugs
    Replace cap after using

  • Dose

    Instill 1 or 2 drops in the affected eyes as needed

  • Eye lubricant

    Eye lubricant

  • Carton

    CMC NAHY

  • INGREDIENTS AND APPEARANCE
    CARBOXYMETHYLCELLULOSE SODIUM EYE DROPS 0.5% 
    carboxymethylcellulose sodium eye drops 0.5% for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16030-501
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) (CARBOXYMETHYLCELLULOSE - UNII:05JZI7B19X) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BORIC ACID (UNII: R57ZHV85D4)  
    SODIUM CHLORITE (UNII: G538EBV4VF)  
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    MANNITOL (UNII: 3OWL53L36A)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG-9 DIGLYCIDYL ETHER/SODIUM HYALURONATE CROSSPOLYMER (UNII: 788QAG3W8A)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:16030-501-055 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product09/20/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34909/20/2022
    Labeler - Aurolab (677319965)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aurolab677319965manufacture(16030-501)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!