Label: FAMILY CARE EYE WASH- purified water solution

  • 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 June 17, 2015

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

  • ACTIVE INGREDIENT

    Drug Facts

    Active ingredient                                                Purpose

    Purified water (99.05%)................................... Eyewash

  • PURPOSE

    Uses

    washes the eye to help relieve

    • irritation
    • discomfort
    • itching
    • stinging
    • burning;

        by removing

    • loose foreign material
    • air pollutants (smog or pollen)
    • chlorinated water
  • WARNINGS

    Warnings

    Do not use

    if solution changes color or becomes cloudy

  • WHEN USING

    When using this product

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

    Stop use and ask a doctor if

    • you experience eye pain, changes in vision, continued redness or irritation of the eye
    • condition worsens or persists
    • you have open wounds in or near the eye
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • INDICATIONS & USAGE

    Directions

    • flush the affected eye(s) as needed
    • control the rate of flow of solution by pressure on the bottle
  • WHEN USING

    When using an eye cup

    • rinse the cup with clean water immediately before each use
    • avoid contamination of the rim and inside surfaces of the cup
    • fill the cup half full and apply the cup to the affected eye(s), pressing tightly to prevent the escape of the liquid
    • tilt the head backward. Open eyelids wide and rotate eyeball to ensure thorough bathing with the wash or lotion
    • rinse the cup with clean water after each use
  • STORAGE AND HANDLING

    Other information

    • store at room temperature
    • keep tightly closed
  • INACTIVE INGREDIENT

    boric acid, edetate disodium, sodium borate, sodium chloride, sodium hydroxide, sodium hydroxide, sorbic acid

  • DOSAGE & ADMINISTRATION

    Distributed by:

    United Exchange Corp.

    17211 Valley View Ave.

    Cerritos, CA 90703 USA

    Made in Korea

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    FAMILY CARE EYE WASH 
    purified water solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-582
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER99.05 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BORIC ACID (UNII: R57ZHV85D4)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SORBIC ACID (UNII: X045WJ989B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65923-582-041 in 1 CARTON
    1118 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 finalpart34906/17/2015
    Labeler - United Exchange Corp. (840130579)