EYE WASH (WATER) SOLUTION [CMC GROUP INC.]

EYE WASH (WATER) SOLUTION [CMC GROUP INC.]
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NDC 49687-0010-1
Set ID 6158a1f5-a6bc-4a3e-9d1d-0a310d9dc561
Category HUMAN OTC DRUG LABEL
Packager CMC Group Inc.
Generic Name
Product Class
Product Number
Application Number PART349
  • Drug Facts

  • ​Active ingredient

    Purified Water 99.1%

    ​Purpose

    Eyewash

  • ​Use

    • For cleansing the eye to help relieve irritaion or burning by removing loose foreign material
  • ​Warnings

    ​For external use only.

    Do not use

    if solution changes color or becomes cloudy

    When using this product

    • to avoid contamination, do not touch tip of container to any surface
    • do not reuse
    • once opened, discard
    • obtain immediate medical treatment for all open wounds in or near the eyes

    Stop use and ask a doctor if

    you experience:

    • eye pain
    • changes in vision
    • continued redness
    • irritation of the eye
    • condition worsens or perisists

    Keep out of reach of children.

    If swallowed, get medical help of contact a Poison Control Center right away.

  • ​Directions

    • Flush the affected eyes as needed, controlling the rate of flow of solution by pressure on the bottle
  • ​Other information

    • not for use as contact len solution
    • use before expiration date marked on the bottle
    • store at room temperature, 5 ​o​ to 35 ​o​C (41 ​o​ to 95 ​o​F)
  • ​Inactive ingredients

    Benzalkonium chloride, sodium chloride

  • Package Labeling:

    Eye wash

  • INGREDIENTS AND APPEARANCE
    EYE WASH 
    water solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49687-0010
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER991 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49687-0010-11 in 1 BOX08/09/2016
    130 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34908/09/2016
    Labeler - CMC Group Inc. (117201448)

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