Label: EYE DROPS ADVANCED RELIEF- tetrahydrozoline hydrochloride, polyethylene glycol 400, dextran 70, povidone solution/ drops

  • NDC Code(s): 62011-0104-1
  • Packager: Strategic Sourcing Services LLC
  • 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.

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Updated September 23, 2019

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  • ACTIVE INGREDIENT

    Active ingredients

    Dextran 70 0.1%

    Polyethylene glycol 400 1%

    Povidone 1%

    Tetrahydrozoline HCl 0.05%

  • PURPOSE

    Purpose

    Dextran 70..........Eye lubricant

    Polyethylene glycol 400.....Eye lubricant

    Povidone.............Eye lubricant

    Tetrahydrozoline HCl.....Redness reliever

  • INDICATIONS & USAGE

    Uses

    • relieves redness of the eye due to minor eye irritations
    • as a lubricant to prevent further irritation or to relieve dryness of the eye
  • WARNINGS

    Warnings

    For external use only

    Ask a doctor before use if you have narrow angle glaucoma

    When using this product

    • pupils may become enlarged temporarily
    • to avoid contamination, do not touch tip of container to any surface. Replace cap after using
    • if solution changes color or becomes cloudy, do not use
    • overuse may product increased redness of the eye
    • remove contact lens before using

    Stop use and ask a doctor if you experience

    • eye pain
    • changes in vision
    • continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

    If pregnant or breastfeeding, ask a health professional before use

  • DOSAGE & ADMINISTRATION

    Directions

    Instill 1 or 2 drops in the affected eye(s)up to four times daily.

  • OTHER SAFETY INFORMATION

    Other information
    Store at 15º-30ºC (59ª-86ºF)

  • INACTIVE INGREDIENT

    Inactive ingredients

    benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate, and sodium chloride.

  • PRINCIPAL DISPLAY PANEL

    Carton HMEyeDrAdvRel.jpg

    Carton

  • INGREDIENTS AND APPEARANCE
    EYE DROPS ADVANCED RELIEF 
    tetrahydrozoline hydrochloride, polyethylene glycol 400, dextran 70, povidone solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62011-0104
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077) TETRAHYDROZOLINE HYDROCHLORIDE0.5 mg  in 1 mL
    POVIDONE (UNII: FZ989GH94E) (POVIDONE - UNII:FZ989GH94E) POVIDONE10 mg  in 1 mL
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ) POLYETHYLENE GLYCOL 40010 mg  in 1 mL
    DEXTRAN 70 (UNII: 7SA290YK68) (DEXTRAN 70 - UNII:7SA290YK68) DEXTRAN 701 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BORIC ACID (UNII: R57ZHV85D4)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62011-0104-11 in 1 CARTON03/01/2012
    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 finalpart34903/01/2012
    Labeler - Strategic Sourcing Services LLC (116956644)
    Registrant - KC Pharmaceuticals, Inc. (174450460)
    Establishment
    NameAddressID/FEIBusiness Operations
    KC Pharmaceuticals, Inc.174450460manufacture(62011-0104) , pack(62011-0104) , label(62011-0104)
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