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

fad first aid direct Buffered Eye and Skin by

Drug Labeling and Warnings

fad first aid direct Buffered Eye and Skin by is a Otc medication manufactured, distributed, or labeled by Cintas Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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®

INGREDIENTS AND APPEARANCE

FAD FIRST AID DIRECT EYEWASH 
purified water solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42961-090
Route of Administration	OPHTHALMIC, IRRIGATION, TOPICAL, CUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R)	WATER	985.77 g  in 1000 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42961-090-01	15 mL in 1 VIAL, SINGLE-USE	07/15/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	07/15/2014

XPECT FIRST AID BUFFERED EYEWASH 
purified water solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42961-091
Route of Administration	OPHTHALMIC, IRRIGATION, TOPICAL, CUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R)	WATER	985.77 g  in 1000 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42961-091-02	5 in 1 BOX	07/15/2014
1	NDC: 42961-091-01	15 mL in 1 VIAL, SINGLE-USE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	07/15/2014

EYEWASH FLUSHING SOLUTION 
purified water solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42961-092
Route of Administration	OPHTHALMIC, IRRIGATION, TOPICAL, CUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R)	WATER	985.77 g  in 1000 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42961-092-01	118 mL in 1 BOTTLE, PLASTIC	07/15/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	07/15/2014

XPECT FIRST AID BUFFERED EYE AND SKIN 
purified water solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42961-093
Route of Administration	OPHTHALMIC, IRRIGATION, TOPICAL, CUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R)	WATER	985.77 g  in 1000 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42961-093-01	118 mL in 1 BOTTLE, PLASTIC	07/15/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	07/15/2014

FAD FIRST AID DIRECT BUFFERED EYE AND SKIN 
purified water solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42961-094
Route of Administration	OPHTHALMIC, IRRIGATION, TOPICAL, CUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R)	WATER	985.77 g  in 1000 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42961-094-01	236 mL in 1 BOTTLE, PLASTIC	07/15/2014
2	NDC: 42961-094-02	474 mL in 1 BOTTLE, PLASTIC	07/15/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	07/15/2014

Labeler - Cintas Corporation (056481716)