Label: OCTIQ LUBRICANT EYE DROPS- dextran 70 hypromellose solution/ drops

  • NDC Code(s): 57483-610-15
  • Packager: Innovus Pharmaceuticals, Inc.
  • 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 December 31, 2022

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  • Active ingredients

    Dextran 70 0.1%

    Hypromellose 2910 0.3%

  • Purpose

    Lubricant

    Lubricant

  • Uses

    • for the temporary relief of burning and irritation due to dryness of the eye
    • for the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun
    • as a protectant against future irritation 
  • Warnings

    For external use only

  • Do not use

    • if solution changes color or becomes cloudy
    • if you are sensitive to any ingredient in this product
  • When using this product

    • to avoid contamination, do not touch tip of container to any surface
    • replace cap after using 
  • Stop use and ask a doctor if

    • you feel eye pain
    • changes in vision occur redness or irritation of the eye gets worse or lasts more than 72 hours
  • Keep out of reach of children 

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

  • Directions

    • Put 1 or 2 drops in the affected eye(s) as needed
  • Other Information 

    • Store at room temperature
  • Inactive ingredients

    Boric acid, disodium edetate, potassium chloride, povidone, purified water, sodium borate, sodium chloride
    Preservative added: benzalkonium choride

  • Questions?

    Call 1.800.996.5122

    (Mon-Fri 9AM-5PM EST)

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    OCTIQ LUBRICANT EYE DROPS 
    dextran 70 hypromellose solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57483-610
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTRAN 70 (UNII: 7SA290YK68) (DEXTRAN 70 - UNII:7SA290YK68) DEXTRAN 701 mg  in 1 mL
    HYPROMELLOSE 2910 (4000 MPA.S) (UNII: RN3152OP35) (HYPROMELLOSE 2910 (4000 MPA.S) - UNII:RN3152OP35) HYPROMELLOSE 2910 (4000 MPA.S)3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BORIC ACID (UNII: R57ZHV85D4)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    POVIDONE (UNII: FZ989GH94E)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57483-610-152 in 1 CARTON11/14/2021
    115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34911/14/2021
    Labeler - Innovus Pharmaceuticals, Inc. (962507187)
    Establishment
    NameAddressID/FEIBusiness Operations
    AMMAN PHARMACEUTICAL INDUSTRIES534677849manufacture(57483-610)
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