Label: EYE WASH liquid

  • 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 September 14, 2016

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  • ACTIVE INGREDIENT

    Active ingredient Purpose

    Purified water (99.1%)..................................... Eyewash

  • PURPOSE

    Eye wash

  • INSTRUCTIONS FOR USE

    • To pour - hold bottle securely, twist off top to remove
    • Control rate of flow by pressure on the bottle
    • Flush the affected eye(s) as needed
    • Do not touch bottle tip to eye
    • If necessary, continue flushing with emergency eyewash or shower.
  • WARNINGS

    Do not use if pack is damaged

    Do not use resterilize and reuse

  • DOSAGE & ADMINISTRATION

    Topical irrigation solution

    0.9% w/v Sodium Chloride

  • INDICATIONS & USAGE

    For topical irrigation of eyes, burns and wounds

  • INACTIVE INGREDIENT

    0.9% w/v Sodium Chloride

  • OTHER SAFETY INFORMATION

    Caution:

    Discard any unused solution

    Single use only

  • STORAGE AND HANDLING

    Store in cool dry place

    Keep out of direct sunlight

    Keep out of reach of children

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • PRINCIPAL DISPLAY PANEL

    NDC# 54429-0107-1

    EYE WASH

    Topical irrigation solution 0.9% w/v Sodium Chloride

    For topical irrigation of eyes, burns and wounds

    CAUTION:

    DISCARD ANY UNUSED SOLUTION

    SINGLE USE ONLY

    DO NOT USE IF PACK IS DAMAGED

    DO NOT RESTERILIZE AND REUSE

    NOT FOR INJECTION

    FOR EXTERNAL USE ONLY

    STORE IN COOL DRY PLACE

    KEEP OUT OF DIRECT SUNLIGHT

    KEEP OUT OF REACH OF CHILDREN

    20 ml

    Made in China

    MANUFACTURED FOR:

    Total Resources Intenational, Walnut CA 91789. USA

    bottle label

  • INGREDIENTS AND APPEARANCE
    EYE WASH 
    eye wash liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54429-0107
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER99.1 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM CHLORITE (UNII: G538EBV4VF)  
    Product Characteristics
    Colorwhite (CLEAR) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54429-0107-120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/14/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34909/14/2016
    Labeler - Foshan Flying Medical Products Co., Ltd. (527021584)
    Registrant - Foshan Flying Medical Products Co., Ltd. (527021584)
    Establishment
    NameAddressID/FEIBusiness Operations
    Foshan Flying Medical Products Co., Ltd.527021584manufacture(54429-0107)
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