Label: HYPROMELLOSE EYE DROPS 0.7% for solution

  • 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 August 23, 2023

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  • Active Ingredient

    Hypromellose 0.7% BP w/v

  • DIRECTIONS FOR USE

    • lnstill 1or 2 drops in the affected eye, as needed
  • INACTIVE INGREDIENT

    1. Benzalkonium Chloride
    2. Borax
    3. Boric acid
    4. EDTA disodium salt
    5. Potassium chloride
    6. Purified water
    7. Sodiumchloride
  • Tamper Protection

    • For your protection a tamper evident ring is attached to the bottlecap
    • Upon opening, this will separate from the cap and can be discarded
    • Use only if this ring is present and attached when the bottle is first opened
  • USE

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

    Call: 1-800-103-7321

    Email: 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
  • ASK DOCTOR

    • If you experience eye pain
    • Change in vision
    • Continued redness(or) irritation of the eye
    • Condition worsens or persists for more than 72 hours
  • DO NOT USE

    • If you are sensitive to any ingredient in this product
    • If solution changes color or becomes cloudy
  • Dosage

    Instill 1 or 2 drops in the affected eyes as needed

  • Warnings

    For External Use Only

  • Indications and Usage

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

  • Eye Lubricant

    Eye Lubricant

  • CARTON LABEL

    HPMC

  • INGREDIENTS AND APPEARANCE
    HYPROMELLOSE EYE DROPS 0.7% 
    hypromellose eye drops 0.7% for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16030-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYPROMELLOSE 2910 (4000 MPA.S) (UNII: RN3152OP35) (HYPROMELLOSE 2910 (4000 MPA.S) - UNII:RN3152OP35) HYPROMELLOSE 2910 (4000 MPA.S)7 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BORIC ACID (UNII: R57ZHV85D4)  
    WATER (UNII: 059QF0KO0R)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:16030-101-1010 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product09/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34909/01/2022
    Labeler - Aurolab (677319965)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aurolab677319965manufacture(16030-101)
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