Label: FAMILY CARE LUBRICANT EYE- polyethylene glycol 400, and propylene glycol 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 May 23, 2017

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

  • ACTIVE INGREDIENT

    Active ingredients                                               Purpose

    Polyethylene glycol 400 0.4%...............................Eye lubricant

    Propylene glycol 0.3%.........................................Eye lubricant

  • PURPOSE

    Use

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

    Warnings

    For external use only

  • DO NOT USE

    Do not use

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

    When using this product

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

    Stop use and ask a doctor if

    • you feel eye pain
    • changes in vision occur
    • redness or irritation of the eye(s) lasts
    • condition worsens or lasts 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

    Other information

    • store at room temperature 20-25°C (68-77°F)
  • INACTIVE INGREDIENT

    Inactive ingredients

    boric acid, calcium chloride, chlorhexidine gluconate, hydrochloric acid, hypromellose, magnesium chloride, potassium chloride, purified water,

    sodium chloride, sodium hydroxide, zinc chloride

  • DOSAGE & ADMINISTRATION

    Distributed by:

    United Exchange Corp.

    17211 Valley View Ave.

    Cerritos, CA 90703 U.S.A.

    www.ueccorp.com

    Made in Korea

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    FAMILY CARE LUBRICANT EYE 
    polyethylene glycol 400, and propylene glycol solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-580
    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
    BORIC ACID (UNII: R57ZHV85D4)  
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    ZINC CHLORIDE (UNII: 86Q357L16B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65923-580-151 in 1 CARTON05/23/2017
    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 finalpart34905/23/2017
    Labeler - United Exchange Corp. (840130579)