Label: REDNESS RELIEVER AND LUBRICANT- dextran 70, polyethylene glycol 400, povidone, tetrahydrozoline hcl liquid

  • 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 July 8, 2022

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  • Active Ingredient

    Dextran 70 0.1%

    Polyethylene Glycol 400 1%

    Povidone 1%

    Tetrahydrozoline HCl 0.5%

  • Purpose

    Lubricant

    Lubricant

    Lubricant

    Redness reliever

  • Use

    • for the relief of redness of the eye due to minor eye irritations
    • for use as a protectant against further irritation or to relieve dryness of the eye
  • Warnings

    Ask a doctor before use if you have narrow angle glaucoma

    When using this product

    • pupils may become enlarged temporarily
    • overuse may cause more eye redness
    • remove contact lenses before using
    • do not use if this solution changes color or become cloudy
    • do not touch tip of container to any surface to avoid contamination
    • replace cap after each use

    Stop use and ask a doctor if

    • you feel eye pain
    • changes in vision occur
    • redness or irritation of the eye lasts
    • condition worsens or lasts more than 72 hours

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

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

  • Directions

    • Put 1 to 2 drops in the affected eye(s) up to 4 times daily
    • children under 6 years of age:  ask a doctor
  • Other information

    • store at 15-30 °C (59-86 °F)

  • Inactive ingredients

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

  • package label

    Redness Reliever and Lubricant

    image of carton label

  • INGREDIENTS AND APPEARANCE
    REDNESS RELIEVER AND LUBRICANT 
    dextran 70, polyethylene glycol 400, povidone, tetrahydrozoline hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58988-0018
    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
    DEXTRAN 70 (UNII: 7SA290YK68) (DEXTRAN 70 - UNII:7SA290YK68) DEXTRAN 701 mg  in 1 mL
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ) POLYETHYLENE GLYCOL 40010 mg  in 1 mL
    POVIDONE (UNII: FZ989GH94E) (POVIDONE - UNII:FZ989GH94E) POVIDONE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BORIC ACID (UNII: R57ZHV85D4)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58988-0018-11 in 1 BOX12/06/2013
    115 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34912/06/2013
    Labeler - Promex, LLC (789974388)
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