Label: WALGREENS MAXIMUM REDNESS RELIEF- glycerin, naphazoline hydrochloride solution

  • Category: HUMAN OTC DRUG LABEL

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 November 25, 2014

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • ACTIVE INGREDIENT

    Active ingredients                                                               Purpose

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

    Naphazoline HCL 0.03% ................................................... 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 the dryness of the eye.
    • for the use as a protectant against further irritation or dryness of the eye.
  • WARNINGS

    Warnings

    For external use only.

  • DO NOT USE

    Do not use if solution changes 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 produce increased 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 or irritation of the eye
    • the condition worsens or persists for more than 72 hours
  • KEEP OUT OF REACH OF CHILDREN

     Keep out of reach of children

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

  • INDICATIONS & USAGE

     Directions

    • to open bottle, push cap down and twist counter-clockwise. To close bottle, twist clockwise until it stops turning.
    • put 1 to 2 drops in the affected eye(s) up to 4 times daily
  • STORAGE AND HANDLING

     Other information

    • store at room temperature (15° to 30°C 59° to 86°F)
    • remove contact lenses before using
  • INACTIVE INGREDIENT

     Inactive ingredients

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

  • DOSAGE & ADMINISTRATION

    DISTRIBUTED BY:

    WALGREEN CO.

    200 WILMOT RD.

    DEERFIELD, IL 60015

    walgreens.com

    Made in Korea

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    WALGREENS MAXIMUM REDNESS RELIEF 
    glycerin, naphazoline hydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-1465
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN0.0025 mg  in 1 mL
    NAPHAZOLINE HYDROCHLORIDE (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV) NAPHAZOLINE HYDROCHLORIDE0.00012 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    BORIC ACID (UNII: R57ZHV85D4)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-1465-151 in 1 CARTON
    115 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34911/25/2014
    Labeler - WALGREEN COMPANY (008965063)