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NDC 16030-0301-02 Aurovisc 20 mg/mL Details

Aurovisc 20 mg/mL

Aurovisc is a OPHTHALMIC SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Aurolab. The primary component is HYPROMELLOSE 2208 (15000 MPA.S).

Product Information

NDC	16030-0301
Product ID	16030-301_ee3de20b-fbc2-3807-e053-2995a90aa6a6
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Aurovisc
Proprietary Name Suffix	n/a
Non-Proprietary Name	Hypromellose Ophthalmic Solution 2% w/v
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION
Route	OPHTHALMIC
Active Ingredient Strength	20
Active Ingredient Units	mg/mL
Substance Name	HYPROMELLOSE 2208 (15000 MPA.S)
Labeler Name	Aurolab
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part349
Listing Certified Through	2023-12-31

Package

Package Images

NDC 16030-0301-02 (16030030102)

Pricing Information	N/A
NDC Package Code	16030-301-02
Billing NDC	16030030102
Package	2 mL in 1 SYRINGE, GLASS (16030-301-02)
Marketing Start Date	2022-09-26
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL e9100312-b105-50a6-e053-2a95a90ac31f Details

ACTIVE INGREDIENT

Hypromellose USP 2% w/v

INACTIVE INGREDIENT

Acetic acid 1%
Calcium chloride
Citric acid 0.1465%
Magnesium Chloride
Sodium chloride
Sodium acetate,
Sodium Citrate
Potassium chloride
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 : [email protected]

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

Transient blurring of vision
Ocular discomfort or irritation
Matting or Stickness of eyelashes
Photophobia
Hypersensitivity or edema of the eyelids

DO NOT USE

If the solution becomes dark brown or any floating particles are observed.
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

hypromellose ophthalmic solution 2% w/v solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:16030-301
Route of Administration	OPHTHALMIC

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

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:16030-301-02	2 mL in 1 SYRINGE, GLASS; Type 1: Convenience Kit of Co-Package	09/26/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part349	09/26/2022

Labeler - Aurolab (677319965)

Name	Address	ID/FEI	Business Operations
Establishment
Aurolab		677319965	manufacture(16030-301)

Revised: 11/2022

Document Id: ee3de20b-fbc2-3807-e053-2995a90aa6a6

Set id: e9100312-b105-50a6-e053-2a95a90ac31f

Version: 2

Effective Time: 20221124