FAD FIRST AID DIRECT EYEWASH (PURIFIED WATER) SOLUTION XPECT FIRST AID BUFFERED EYEWASH (PURIFIED WATER) SOLUTION EYEWASH FLUSHING SOLUTION (PURIFIED WATER) SOLUTION XPECT FIRST AID BUFFERED

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  • FAD FIRST AID DIRECT EYEWASH (PURIFIED WATER) SOLUTION XPECT FIRST AID BUFFERED EYEWASH (PURIFIED WATER) SOLUTION EYEWASH FLUSHING SOLUTION (PURIFIED WATER) SOLUTION XPECT FIRST AID BUFFERED

FAD FIRST AID DIRECT EYEWASH (PURIFIED WATER) SOLUTION XPECT FIRST AID BUFFERED EYEWASH (PURIFIED WATER) SOLUTION EYEWASH FLUSHING SOLUTION (PURIFIED WATER) SOLUTION XPECT FIRST AID BUFFERED
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NDC 42961-090-01, 42961-091-01, 42961-091-02, 42961-092-01, 42961-093-01, 42961-094-01, 42961-094-02
Set ID d38a90ce-4733-4abb-a2ac-8176273a6515
Category HUMAN OTC DRUG LABEL
Packager Cintas Corporation
Generic Name
Product Class
Product Number
Application Number PART349
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  • Active ingredient

    Purified water 98.577% w/v

  • Purpose

    eye wash

  • Uses

    •
    For flushing the eye to remove loose foreign material or air pollutants (smog or pollen)
  • Warnings

    For external use only

    Do not use

    •
    If solution changes color or becomes cloudy

    When using this product

    •
    Remove contact lenses before using
    •
    Avoid contamination, do not touch tip of container to any surface
    •
    Do not reuse, once open, discard

    Stop use and ask a doctor if

    •
    You experience eye pain
    •
    Changes in vision occur
    •
    Continued redness or irritation of the eye or if the condition worsens or persists
    •
    Obtain immediate medical treatment for all open wounds in or near the eyes

     

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

  • Directions

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

    •
    Store out of direct sunlight 2°-40°C (36°-104°F)
    •
    Use at 15°-30°C (59°-86°F)
    •
    Do not use if twist-off top is broken or missing
  • Inactive ingredients

    disodium EDTA, polyhexanide (PHMB), sodium chloride, sodium hydroxide, sodium phosphate dibasic, sodium phosphate monobasic

  • Package /Label Principal Display Panel – fad first aid direct Eyewash

    fad first aid direct Eyewash label
  • Package/Label Principal Display Panel – Xpect First aid Buffered Eyewash

    Xpect First aid Buffered Eyewash label
  • Package/Label Principal Display Panel – Eyewash Flushing Solution

    Eyewash Flushing Solution label

    Eyewash

    FLUSHING SOLUTION

    Sterile
    Isotonic Buffered
    Flushing Solution

    Single Use Only

    CAUTION: Tamper-evident cap.
    Do not use if twist-off top is broken or missing.

    4 fl. oz. (118 mL)

  • Package/Label Principal Display Panel – Xpect First aid Buffered Eye & Skin

    Xpect First aid Buffered Eye & Skin label

    BUFFERED
    Eye & Skin

    Sterile Isotonic
    Buffered Flushing Solution

    Single use only

    CAUTION: Tamper-evident cap.
    Do not use if twist-off top is broken or missing.

    4 fl. oz. (118 mL)

    Xpect®
    First aid

  • Package/Label Principal Display Panel – fad first aid direct Buffered Eye & Skin

    fad first aid direct Buffered Eye & Skin Sterile Isotonic Buffered Flushing Solution label

    BUFFERED
    Eye & Skin

    Sterile
    Isotonic Buffered
    Flushing Solution

    SINGLE USE ONLY

    CAUTION: Tamper-evident cap. Do not use if twist-off top is broken or missing.

    8 fl. oz. (236 mL)

    fad first aid direct®

  • Package/Label Principal Display Panel – fad first aid direct Buffered Eye & Skin

    fad first aid direct Buffered Eye & Skin Sterile Isotonic Buffered Flushing Solution label

    BUFFERED
    Eye & Skin

    Sterile
    Isotonic Buffered
    Flushing Solution

    SINGLE USE ONLY

    CAUTION: Tamper-evident cap. Do not use if twist-off top is broken or missing.

    16 fl. oz. (474 mL)

    fad first aid direct®

  • INGREDIENTS AND APPEARANCE
    FAD FIRST AID DIRECT EYEWASH 
    purified water solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42961-090
    Route of AdministrationOPHTHALMIC, IRRIGATION, TOPICAL, CUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER985.77 g  in 1000 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLIHEXANIDE (UNII: 322U039GMF)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATE (UNII: E1W4N241FO)  
    SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42961-090-0115 mL in 1 VIAL, SINGLE-USE07/15/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34907/15/2014
    XPECT FIRST AID BUFFERED EYEWASH 
    purified water solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42961-091
    Route of AdministrationOPHTHALMIC, IRRIGATION, TOPICAL, CUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER985.77 g  in 1000 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLIHEXANIDE (UNII: 322U039GMF)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATE (UNII: E1W4N241FO)  
    SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42961-091-025 in 1 BOX07/15/2014
    1NDC:42961-091-0115 mL in 1 VIAL, SINGLE-USE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34907/15/2014
    EYEWASH FLUSHING SOLUTION 
    purified water solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42961-092
    Route of AdministrationOPHTHALMIC, IRRIGATION, TOPICAL, CUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER985.77 g  in 1000 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLIHEXANIDE (UNII: 322U039GMF)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATE (UNII: E1W4N241FO)  
    SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42961-092-01118 mL in 1 BOTTLE, PLASTIC07/15/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34907/15/2014
    XPECT FIRST AID BUFFERED EYE AND SKIN 
    purified water solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42961-093
    Route of AdministrationOPHTHALMIC, IRRIGATION, TOPICAL, CUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER985.77 g  in 1000 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLIHEXANIDE (UNII: 322U039GMF)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATE (UNII: E1W4N241FO)  
    SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42961-093-01118 mL in 1 BOTTLE, PLASTIC07/15/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34907/15/2014
    FAD FIRST AID DIRECT BUFFERED EYE AND SKIN 
    purified water solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42961-094
    Route of AdministrationOPHTHALMIC, IRRIGATION, TOPICAL, CUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER985.77 g  in 1000 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLIHEXANIDE (UNII: 322U039GMF)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATE (UNII: E1W4N241FO)  
    SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42961-094-01236 mL in 1 BOTTLE, PLASTIC07/15/2014
    2NDC:42961-094-02474 mL in 1 BOTTLE, PLASTIC07/15/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34907/15/2014
    Labeler - Cintas Corporation (056481716)
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