AURO-CMC- carboxymethylcellulose eye drops 0.5% for solution

AURO-CMC by

Drug Labeling and Warnings

AURO-CMC by is a Otc medication manufactured, distributed, or labeled by Aurolab. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

AURO-CMC 
carboxymethylcellulose eye drops 0.5% for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 16030-401
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) (CARBOXYMETHYLCELLULOSE - UNII:05JZI7B19X)	CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED	5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 16030-401-10	10 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	09/20/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	09/20/2022

Labeler - Aurolab (677319965)

Establishment
Name	Address	ID/FEI	Business Operations
Aurolab		677319965	manufacture(16030-401)