Label: RED EYE RELIEF- glycerin, and naphazoline hydrochloride 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 March 4, 2015

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  • ACTIVE INGREDIENT

    Active ingredients                                                Purpose

    Glycerin 0.5%................................................... Lubricant

    Naphazoline hydrochloride 0.33%........................ Redness Reliever

  • PURPOSE

    Uses

    • For the relief of redness of the eye due to minor eye irritations
    • For the temporary relief of burning and irritation due to dryness of the eye
    • For use as a protectant against futher irritation or to relive dryness of the eye
  • WARNINGS

    Warnings

    For external use only

  • DO NOT USE

    Do not use

    • if solution changes color or becomes cloudy
  • ASK DOCTOR

    Ask a doctor before use

    • if you have narrow angle glaucoma
  • WHEN USING

    When using this product

    • to avoid contamination, do not touch tip of container to any surface
    • replace cap after using
    • overuse may product icreased redness of the eye
    • pupils may become enlarged temporarily
  • STOP USE

    Stop use and ask a doctor if

    • you experience eye pain
    • you experience changes in vision
    • you experience continued redness of the eye
    • pupils may become enlarged temporarily
  • KEEP OUT OF REACH OF CHILDREN

    Stop use and ask a doctor if

    • you experience eye pain
    • you experience changes in vision
    • you experience continued redness or irritation of the eye
    • the condition worsens
    • symptoms persist for more than 72 hours
  • INDICATIONS & USAGE

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

  • STORAGE AND HANDLING

    Directions

    • To open bottle, push cap down and twist counterclockwise. To close bottle, twist clockwise until it stops turning
  • INACTIVE INGREDIENT

    Inactive ingredients:

    Benzalkonium Choride, Boric Acid, Disodium Edetate Hydrate, Sodium Borate, Sterile Purified Water

  • DOSAGE & ADMINISTRATION

    DISTRIBUTED BY:

    TARGET CORPORATION

    MINNEAPOLIS, MN 55403

    MADE IN KOREA

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    RED EYE RELIEF 
    glycerin, and naphazoline hydrochloride solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11673-578
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN500 mg  in 100 mL
    NAPHAZOLINE HYDROCHLORIDE (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV) NAPHAZOLINE HYDROCHLORIDE30 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    BORIC ACID (UNII: R57ZHV85D4)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11673-578-151 in 1 BOX
    115 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34903/04/2015
    Labeler - Target Corporation (006961700)