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 EYE AND SKIN- purified water solution 
FAD FIRST AID DIRECT BUFFERED EYE AND SKIN- purified water solution 
Cintas Corporation

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.

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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

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®

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)

Revised: 7/2014
Document Id: d38a90ce-4733-4abb-a2ac-8176273a6515
Set id: d38a90ce-4733-4abb-a2ac-8176273a6515
Version: 1
Effective Time: 20140715
 
Cintas Corporation