Label: WALGREENS EYE DROPS MAXIMUM REDNESS RELIEF 15ML- glycerin, naphazoline hci 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 October 11, 2019

If you are a consumer or patient please visit this version.

  • Active ingredients

    Glycerin 0.5%

    Naphazoline hydrochloride 0.03%

  • Purposes

    Lubricant

    Redness Reliever

  • 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 further irritation or dryness of the eye

  • Warnings

    For external use only

    Do not use

    if solution changes color or becomes cloudy

    Ask a doctor before use if you have

    narrow angle glaucoma

    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 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.

    If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    instill 1 or 2 drops in the affected eye(s) up to 4 times daily.

  • Other information

    • store at room temperature

    • remove contact lenses before using

  • Inactive ingredients

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

  • Walgreens Eye Drops Maximum Redness Relief 15mL

    Walgreens Eye Drops Maximum Redness Relief 15mL

  • INGREDIENTS AND APPEARANCE
    WALGREENS EYE DROPS MAXIMUM REDNESS RELIEF 15ML 
    glycerin, naphazoline hci liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-4546
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NAPHAZOLINE HYDROCHLORIDE (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV) NAPHAZOLINE HYDROCHLORIDE0.03 g  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN0.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BORIC ACID (UNII: R57ZHV85D4)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-4546-011 in 1 BOX10/10/2019
    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 finalpart34910/10/2019
    Labeler - Walgreen Company (008965063)
    Registrant - KC Pharmaceuticals, Inc. (174450460)
    Establishment
    NameAddressID/FEIBusiness Operations
    KC Pharmaceuticals, Inc.174450460manufacture(0363-4546) , pack(0363-4546) , label(0363-4546)