EYE WASH LIQUID [GUANGDONG COMFORT MEDICAL PRODUCTS CO., LTD.]

EYE WASH LIQUID [GUANGDONG COMFORT MEDICAL PRODUCTS CO., LTD.]
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NDC 71584-0107-1, 71584-0107-2
Set ID 548d9fb4-bd57-74c1-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager Guangdong Comfort Medical Products Co., Ltd.
Generic Name
Product Class
Product Number
Application Number PART349
  • 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 label0107-2 label

  • INGREDIENTS AND APPEARANCE
    EYE WASH 
    eye wash liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71584-0107
    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:71584-0107-120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/17/2017
    2NDC:71584-0107-220 mL in 1 BOTTLE; Type 0: Not a Combination Product06/13/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34907/17/2017
    Labeler - Guangdong Comfort Medical Products Co., Ltd. (544507534)
    Registrant - Guangdong Comfort Medical Products Co., Ltd. (544507534)

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