Label: AURO-CMC- carboxymethylcellulose eye drops 0.5% for solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 2, 2025

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  • Active ingredient

    Carboxymethylcellulose sodium IP 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. Magnesium chloride
    4. Potassium chloride
    5. Water
    6. Sodium tetra borate
  • 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.You experience eye pain

    2.Change in vision Continued redness (or) irritation of the eye

  • 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
    Replace cap after using

  • Dose

    Instill 1 or 2 drops in the affected eyes as needed

  • Eye lubricant

    Eye lubricant

  • PACKAGE CARTON

    CMC CARTON

  • INGREDIENTS AND APPEARANCE
    AURO-CMC 
    carboxymethylcellulose eye drops 0.5% for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16030-401
    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)  
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:16030-401-1010 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 DrugM01809/20/2022
    Labeler - Aurolab (677319965)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aurolab677319965manufacture(16030-401)
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