Label: WALGREENS MULTI-SYMPTOM RELIEF EYE DROPS- glycerin, hypromellose, polyethylene glycol 400, tetrahydrozoline hcl, zinc sulfate 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 6, 2020

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  • ACTIVE INGREDIENT

    Active ingredients

    Glycerin ....0.2%

    Hypromellose.....0.36%

    Polyethylene glycol 400.....1%

    Tetrahydrozoline HCl.....0.05%

    Zinc sulfate 0.25%

  • PURPOSE

    Purposes

    Glycerin ....Lubricant

    Hypromellose.....Lubricant

    Polyethylene glycol 400.....Lubricant

    Tetrahydrozoline HCl.....Redness reliever

    Zinc sulfate.....Astringent

  • INDICATIONS & USAGE

    Uses

    • for temporary relief of discomfort and redness of the eye due to minor eye irritations
    • relieves dryness of the eye
    • for temporary relief of burning and irritation due to exposure to wind or sun
    • for protection against further irritation
  • PURPOSE

    ​Uses

    • for temporary relief of discomfort and redness of the eye due to minor eye irritations
    • relieves dryness of the eye
    • for temporary relief of burning and irritation due to exposure to wind or sun
    • for protection against further irritation
  • 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
    • overuse may cause more eye redness
    • remove contact lenses before using
    • do not touch tip of container to any surface to avoid contamination
    • replace cap after using
    • do not use if this solution changes color or becomes cloudy

    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 (1-800-222-1222) right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • instill 1 to 2 drops in the affected eye(s) up to 4 times daily
    • children under 6 years of age: ask a doctor
  • OTHER SAFETY INFORMATION

    Other information

    • some users may experience a brief tingling sensation
    • store at 20º-25ºC (68º-77ºF)
  • INACTIVE INGREDIENT

    Inactive ingredients

    • benzalkonium chloride, boric acid, edetate disodium, purified water, sodium chloride, sodium citrate
  • QUESTIONS

    Questions or comments?

    1-888-527-4276

  • PRINCIPAL DISPLAY PANEL

    carton

  • INGREDIENTS AND APPEARANCE
    WALGREENS MULTI-SYMPTOM RELIEF EYE DROPS 
    glycerin, hypromellose, polyethylene glycol 400, tetrahydrozoline hcl, zinc sulfate solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-1462
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN0.2 g  in 100 mL
    TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077) TETRAHYDROZOLINE HYDROCHLORIDE0.05 g  in 100 mL
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) (HYPROMELLOSE, UNSPECIFIED - UNII:3NXW29V3WO) HYPROMELLOSE, UNSPECIFIED0.36 g  in 100 mL
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ) POLYETHYLENE GLYCOL 4001 g  in 100 mL
    ZINC SULFATE (UNII: 89DS0H96TB) (ZINC CATION - UNII:13S1S8SF37) ZINC SULFATE0.25 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BORIC ACID (UNII: R57ZHV85D4)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    WATER (UNII: 059QF0KO0R)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-1462-011 in 1 CARTON03/06/2020
    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 finalpart34903/06/2020
    Labeler - Walgreen Co. (008965063)
    Registrant - K.C. Pharmaceuticals, Inc. (174450460)
    Establishment
    NameAddressID/FEIBusiness Operations
    K.C. Pharmaceuticals, Inc.174450460manufacture(0363-1462) , pack(0363-1462) , label(0363-1462)
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