Label: ARCHIES DRY EYE RELIEF- polyethylene glycol 400, propylene glycol solution/ drops

  • NDC Code(s): 83737-001-30, 83737-001-60
  • Packager: Archie's Remedies
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 15, 2023

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  • Active ingredients

    Polyethylene glycol 400 0.4%

    Propylene glycol 0.3%

  • Purposes

    Lubricant

    Lubricant

  • Use

    • for the temporary relief of burning and irritation of the eye due to dryness of the eye
  • Warnings

    For external use only

    Do not use

    • if this solution changes color or becomes cloudy
    • if you are sensitive to any ingredient in this product

    When using this product

    • to avoid contamination, do not touch tip of container to any surface.
    • do not reuse. Once opened, discard.

    Stop use and ask a doctor if

    • you feel eye pain
    • changes in vision occur
    • redness or irritation of the eye(s) gets worse 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.

  • Directions

    • instill 1 or 2 drops in the affected eye(s) as needed
  • Other information

    • store at 15°-25°C (59°-77°F)
    • use only if single-use container is intact
    • use before expiration date marked on container
    • RETAIN THIS CARTON FOR FUTURE REFERENCE
  • Inactive ingredients

    boric acid, hypromellose, potassium chloride, purified water, sodium chloride. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

  • Archie's Dry Eye Relief 30ct

    Archie's Dry Eye Relief 30ct

  • Archie's Dry Eye Relief 60ct

    Archie's Dry Eye Relief 60ct

  • INGREDIENTS AND APPEARANCE
    ARCHIES DRY EYE RELIEF 
    polyethylene glycol 400, propylene glycol solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83737-001
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ) POLYETHYLENE GLYCOL 4000.4 g  in 100 mL
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3) PROPYLENE GLYCOL0.3 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    WATER (UNII: 059QF0KO0R)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    BORIC ACID (UNII: R57ZHV85D4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83737-001-3030 in 1 BOX10/16/2023
    10.4 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    2NDC:83737-001-6060 in 1 BOX10/16/2023
    20.4 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01810/16/2023
    Labeler - Archie's Remedies (118986599)
    Registrant - KC Pharmaceuticals, Inc. (174450460)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unimed Pharmaceuticals, Inc.689852052manufacture(83737-001) , pack(83737-001) , label(83737-001)
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