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

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

HPMC

AUROVISC LUBRICANT HYPROMELLOSE 2208 (15000 MPA.S) SOLUTION/DROPS 
hypromellose ophthalmic solution 2% w/v solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16030-302
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
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 NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:16030-302-022 mL in 1 SYRINGE, GLASS; Type 1: Convenience Kit of Co-Package09/26/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34909/26/2022
Labeler - Aurolab (677319965)
Establishment
NameAddressID/FEIBusiness Operations
Aurolab677319965manufacture(16030-302)

Revised: 1/2023
Document Id: f27a4b27-491b-e5fd-e053-2995a90a0560
Set id: f27a44dc-c420-ed92-e053-2995a90a1640
Version: 1
Effective Time: 20230111
 
Aurolab