FDA.reportPublic FDA data

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

Manufacturer
Aurolab
Effective date
2023-01-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:53:18

Label at a glance#

ProductAurovisc Lubricant HYPROMELLOSE 2208 (15000 MPA.S) Solution/Drops
Active ingredientHYPROMELLOSE 2208 (15000 MPA.S)
Label structure12 sections

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Hypromellose USP 2% w/v

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

  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

INDICATIONS & USAGE SECTION

For use as a lubricant to prevent further irritation or to relieve dryness of the eye

QUESTIONS

OTC - QUESTIONS SECTION

Call. 1-800-103-7321,

E-mail : info@aurolab.com
Web : www.aurolab.com

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed get medical help or contact a Poison Control Center right away.

STOP USE

OTC - STOP USE SECTION

  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

OTC - DO NOT USE SECTION

  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

WARNINGS SECTION

For External use only

INDIACATIONS AND USAGE

INDICATIONS & USAGE SECTION

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

Purpose

OTC - PURPOSE SECTION

Lubricant

Dose

DOSAGE & ADMINISTRATION SECTION

Instill 1 or 2 drops in the affected eyes as needed

PACKAGE CARTON

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HPMCHPMC

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1147664hypromellose 2 % Ophthalmic SolutionPSN1
1147664hypromellose 20 MG/ML Ophthalmic SolutionSCD1
1147664hypromellose 2 % Ophthalmic SolutionSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
16030-302-022025-01-30C16284748780-12cef2736-6f66-d83d-e063-dadaa90ab31ff27a44dc-c420-ed92-e053-2995a90a1640

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16030-302-02Aurovisc Lubricant HYPROMELLOSE 2208 (15000 MPA.S) Solution/Drops2 mL in 1 SYRINGE, GLASSSOLUTION/ DROPS21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16030-302AUROVISC LUBRICANT HYPROMELLOSE 2208 (15000 MPA.S) SOLUTION/DROPS (HYPROMELLOSE OPHTHALMIC SOLUTION 2% W/V) SOLUTION/ DROPS [AUROLAB]11 package rows20230118_f27a44dc-c420-ed92-e053-2995a90a1640.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
16030-30216030-302-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM CITRATE1Q73Q2JULRIACT
SODIUM ACETATE4550K0SC9BIACT
POTASSIUM CHLORIDE660YQ98I10IACT
WATER059QF0KO0RIACT
SODIUM CHLORIDE451W47IQ8XIACT
MAGNESIUM CHLORIDE02F3473H9OIACT
CALCIUM CHLORIDEM4I0D6VV5MIACT
CITRIC ACID ACETATEDSO12WL7AUIACT
HYPROMELLOSE 2208 (15000 MPA.S)Z78RG6M2N2ACTIB
ACETIC ACIDQ40Q9N063PIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f27a4b27-491b-e5fd-e053-2995a90a0560f27a44dc-c420-ed92-e053-2995a90a16402023-01-11WarningsExact identifier
spl id: f27a4b27-491b-e5fd-e053-2995a90a0560
spl set id: f27a44dc-c420-ed92-e053-2995a90a1640

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.