AUROVISC LUBRICANT HYPROMELLOSE 2208 (15000 MPA.S) GEL/DROPS- hypromellose ophthalmic solution 2% w/v solution, gel forming / drops

Aurovisc Lubricant HYPROMELLOSE 2208 (15000 MPA.S) Gel/Drops by

Drug Labeling and Warnings

Aurovisc Lubricant HYPROMELLOSE 2208 (15000 MPA.S) Gel/Drops by is a Otc medication manufactured, distributed, or labeled by Aurolab. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Hypromellose USP 2% w/v

INACTIVE INGREDIENT

1. Acetic acid 1%
2. Calcium chloride
3. Citric acid 0.1465%
4. Magnesium Chloride
5. Sodium chloride
6. Sodium acetate,
7. Sodium Citrate
8. Potassium chloride
9. Purified water.

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

1. Transient blurring of vision
2. Ocular discomfort or irritation
3. Matting or Stickness of eyelashes
4. Photophobia
5. Hypersensitivity or edema of the eyelids

DO NOT USE

1. If the solution becomes dark brown or any floating particles are observed.
2. If you are sensitive to any ingredient in this product

WARNINGS

For External use only

INDIACATIONS AND USAGE

Do not use if package is damaged
Discard after a single use
Do not freeze
Do not resterilize

Purpose

Lubricant

Dose

Instill 1 or 2 drops in the affected eyes as needed

PACKAGE CARTON

INGREDIENTS AND APPEARANCE

AUROVISC LUBRICANT HYPROMELLOSE 2208 (15000 MPA.S) GEL/DROPS 
hypromellose ophthalmic solution 2% w/v solution, gel forming / drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 16030-303
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYPROMELLOSE 2208 (15000 MPA.S) (UNII: Z78RG6M2N2) (HYPROMELLOSE 2208 (15000 MPA.S) - UNII:Z78RG6M2N2)	HYPROMELLOSE 2208 (15000 MPA.S)	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SODIUM ACETATE (UNII: 4550K0SC9B)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)
CITRIC ACID ACETATE (UNII: DSO12WL7AU)
ACETIC ACID (UNII: Q40Q9N063P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 16030-303-02	2 mL in 1 SYRINGE, GLASS; Type 1: Convenience Kit of Co-Package	09/26/2022	12/31/2027

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M018	09/26/2022	12/31/2027

Labeler - Aurolab (677319965)

Establishment
Name	Address	ID/FEI	Business Operations
Aurolab		677319965	manufacture(16030-303)