AURO-CMC- carboxymethylcellulose eye drops 0.5% for solution 
Aurolab

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.

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Active ingredient

Carboxymethylcellulose sodium IP 0.5% w/v

DIRECTIONS FOR USE

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

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)

Revised: 8/2023
Document Id: 039b9ee7-e912-f323-e063-6294a90ab428
Set id: e90b397f-fe64-8674-e053-2995a90a223f
Version: 4
Effective Time: 20230823
 
Aurolab