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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated January 11, 2023

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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

  • INGREDIENTS AND APPEARANCE
    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)
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