Label: FAMILY CARE ULTRA LUBRICANT- polyethylene glycol 400, and propylene glycol solution/ drops

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated July 26, 2024

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

  • ACTIVE INGREDIENT

    Drug Facts

    Active ingredients Purpose

    Polyethylene Glycol 400 0.4%....................... Eye lubricant

    Propylene Glycol 0.3%....................................Eye lubricant

  • PURPOSE

    Uses

    • for the temporary relief of burning and irritation due to:
    • dryness of the eyes
    • exposure to wind or sun
  • WARNINGS

    Warnings

    For external use only

  • DO NOT USE

    Do not use

    • if this product changes color or becomes cloudy
    • if you are sensitive to any ingredient is this product
  • WHEN USING

    When using this product

    • remove contact lenses before use
    • replace cap after each use
    • do not touch tip of bottle to any surface to avoid contamination
  • STOP USE

    Stop use and ask a doctor if

    • you experience eye pain and/or vision change
    • you continue to have eye redness and/or irritation
    • irritation, burning persists or worsens for more than 72 hours
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

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

  • INDICATIONS & USAGE

    Directions

    • shake well before using
    • instill 1 or 2 drops in the affected eye(s) as needed
    • children under 6 years of age: ask a doctor
  • STORAGE AND HANDLING

  • INACTIVE INGREDIENT

    Inactive ingredients

    benzalkonium chloride, boric acid, hypromellose, hydrochloric acid, potassium chloride, purified water, sodium chloride, sodium hydroxide

  • DOSAGE & ADMINISTRATION

    Distributed by:

    United Exchange Corp,

    Cypress, CA 90630 USA

    1-888-645-8204

    Made in South Korea

  • PRINCIPAL DISPLAY PANEL

    588

  • INGREDIENTS AND APPEARANCE
    FAMILY CARE ULTRA LUBRICANT 
    polyethylene glycol 400, and propylene glycol solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-588
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ) POLYETHYLENE GLYCOL 4004 mg  in 1 mL
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3) PROPYLENE GLYCOL3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    WATER (UNII: 059QF0KO0R)  
    BORIC ACID (UNII: R57ZHV85D4)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65923-588-151 in 1 CARTON07/22/2024
    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 DrugM01807/22/2024
    Labeler - United Exchange Corp. (840130579)