Label: SUNMARK LUBRICANT EYE DROPS- polypropylene glycol 400, propylene glycol solution/ drops

  • NDC Code(s): 49348-947-29
  • Packager: Strategic Sourcing Services LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 23, 2023

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

View All Sections
  • Active Ingredients

    Polyethylene glycol 400 0.4%, Propylene glycol 0.3%

  • Purpose

    Lubricant

  • Uses

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

  • Warnings

    For external use only

    Do not use

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

    When using this product

    • do not touch the tip of the container to any surface to avoid contamination
    • replace cap after each use

    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

    Keep out of reach of children

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

  • Directions

    • instill 1 or 2 drops in the affected eye(s) as needed
    • children under 6 years of age: ask a doctor
  • Other information

    • RETAIN THIS CARTON FOR FUTURE REFERENCE
    • Store at room temperature
  • Inactive ingredients

    Benzalkonium chloride as preservative, boric acid, calcium chloride, hypromellose, magnesium chloride, potassium chloride, purified water, sodium borate, sodium chloride, zinc chloride

  • PRINCIPAL DISPLAY PANEL

    Carton

  • INGREDIENTS AND APPEARANCE
    SUNMARK LUBRICANT EYE DROPS 
    polypropylene glycol 400, propylene glycol solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-947
    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
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    BORIC ACID (UNII: R57ZHV85D4)  
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ZINC CHLORIDE (UNII: 86Q357L16B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49348-947-291 in 1 CARTON12/01/2010
    115 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01812/01/2010
    Labeler - Strategic Sourcing Services LLC (116956644)
    Registrant - KC Pharmaceuticals, Inc (174450460)
    Establishment
    NameAddressID/FEIBusiness Operations
    KC Pharmaceuticals, Inc.174450460manufacture(49348-947) , pack(49348-947) , label(49348-947)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!