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fad first aid direct Eyewash

Dosage form: solution
Ingredients: WATER 985.77g in 1000mL
Labeler: Cintas Corporation
NDC Code: 42961-090

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 Facts

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

Package/Label Principal Display Panel – Xpect First aid Buffered Eyewash

Package/Label Principal Display Panel – Eyewash Flushing Solution

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

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

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

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®

FAD FIRST AID DIRECT EYEWASH 
purified water solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42961-090
Route of AdministrationOPHTHALMIC, IRRIGATION, TOPICAL, CUTANEOUSDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
WATER (WATER) WATER985.77 g  in 1000 mL
Inactive Ingredients
Ingredient NameStrength
POLIHEXANIDE 
EDETATE DISODIUM 
SODIUM HYDROXIDE 
SODIUM CHLORIDE 
SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATE 
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE 
Packaging
#Item CodePackage Description
1NDC:42961-090-0115 mL in 1 VIAL, SINGLE-USE
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, CUTANEOUSDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
WATER (WATER) WATER985.77 g  in 1000 mL
Inactive Ingredients
Ingredient NameStrength
POLIHEXANIDE 
EDETATE DISODIUM 
SODIUM HYDROXIDE 
SODIUM CHLORIDE 
SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATE 
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE 
Packaging
#Item CodePackage Description
1NDC:42961-091-025 VIAL, SINGLE-USE in 1 BOX
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, CUTANEOUSDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
WATER (WATER) WATER985.77 g  in 1000 mL
Inactive Ingredients
Ingredient NameStrength
POLIHEXANIDE 
EDETATE DISODIUM 
SODIUM HYDROXIDE 
SODIUM CHLORIDE 
SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATE 
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE 
Packaging
#Item CodePackage Description
1NDC:42961-092-01118 mL in 1 BOTTLE, PLASTIC
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, CUTANEOUSDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
WATER (WATER) WATER985.77 g  in 1000 mL
Inactive Ingredients
Ingredient NameStrength
POLIHEXANIDE 
EDETATE DISODIUM 
SODIUM HYDROXIDE 
SODIUM CHLORIDE 
SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATE 
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE 
Packaging
#Item CodePackage Description
1NDC:42961-093-01118 mL in 1 BOTTLE, PLASTIC
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, CUTANEOUSDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
WATER (WATER) WATER985.77 g  in 1000 mL
Inactive Ingredients
Ingredient NameStrength
POLIHEXANIDE 
EDETATE DISODIUM 
SODIUM HYDROXIDE 
SODIUM CHLORIDE 
SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATE 
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE 
Packaging
#Item CodePackage Description
1NDC:42961-094-01236 mL in 1 BOTTLE, PLASTIC
2NDC:42961-094-02474 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34907/15/2014
Labeler - Cintas Corporation (056481716)

Revised: 07/2014
 
Cintas Corporation

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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