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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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

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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 finalpart34909/20/2022
    Labeler - Aurolab (677319965)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aurolab677319965manufacture(16030-401)
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