Eyes Alive Eye Wash (Water) Solution [Division 5 Labs, Inc.] -

EYES ALIVE EYE WASH (WATER) SOLUTION [DIVISION 5 LABS, INC.]
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NDC	69183-230-00, 69183-230-01, 69183-230-04, 69183-230-16, 69183-230-20, 69183-230-32, 69183-230-40
Set ID	da3c4e11-a239-43b1-9c62-ae9d3cb87246
Category	HUMAN OTC DRUG LABEL
Packager	DIVISION 5 LABS, INC.
Generic Name
Product Class
Product Number
Application Number	PART349

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SPL UNCLASSIFIED SECTION

Drug Facts
Active Ingredient

Purified Water 98%
Purpose

Emergency eye wash and skin flush
Indications

For flushing the eye to help relieve irritation, discomfort, burning, stinging, smarting or itching by removing loose foreign material, air pollutants (smog or pollen) or chlorinated water.
Warnings
For external use only
- To avoid contamination, do not touch tip of bottle to any surface
- Do not reuse
- Once opened, discard
Do not use

If solution changes colors or becomes cloudy
- With contact lenses
- If bottle is opened or seal is broken
Stop use and consult a doctor if you experience

Eye pain
- Changes in vision
- Continued redness or irritation of the eye or if the condition worsen 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
To pour-hold bottle securely, twist off top to remove
- Control rate of flow by pressure on the bottle
- Flush the affected eye as needed
- Do not touch bottle tip to eye.
Other Information
Tamper-evident cap: Do not use if twist off top is broken or missing
- Twist cap to open
- Use before expiration date marked on bottle
- Store at room temperature, 15°-30° C (59° to 86°F).
Inactive Ingredients

Benzalkonium chloride, edetate disodium dihydrate, sodium chloride, sodium phosphate dibasic heptahydrate, sodium phosphate monobasic monohydrate.
Questions or Comments?

Call 800.477.2884, M-F 9 am-5 pm Eastern time
PRINCIPAL DISPLAY PANEL - 946 mL Bottle Label

EMERGENCY
EYE WASH

Eyes
Alive™

Eye Wash
Sterile Buffered Isotonic Saline Solution

Single Use

Item # D5L-235
Mfd. for Division5 Labs, Inc.
7555 West 2nd Court
Miami, FL 33014
www.division5labs.com

32 fl.oz. (946 mL)

MADE IN
THE USA

INGREDIENTS AND APPEARANCE

EYES ALIVE EYE WASH
water solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69183-230
Route of Administration	OPHTHALMIC

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Water (UNII: 059QF0KO0R) (Water - UNII:059QF0KO0R)	Water	980 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
Benzalkonium chloride (UNII: F5UM2KM3W7)
edetate disodium (UNII: 7FLD91C86K)
sodium chloride (UNII: 451W47IQ8X)
sodium phosphate, dibasic, heptahydrate (UNII: 70WT22SF4B)
sodium phosphate, monobasic, monohydrate (UNII: 593YOG76RN)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69183-230-32	946 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2017
2	NDC:69183-230-16	474 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2017
3	NDC:69183-230-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2017
4	NDC:69183-230-20	2 in 1 CARTON	02/01/2017
4	NDC:69183-230-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC:69183-230-40	4 in 1 CARTON	02/01/2017
5	NDC:69183-230-00	15 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part349	02/01/2017

Labeler - DIVISION 5 LABS, INC. (968198288)

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Medic

EYES ALIVE EYE WASH (WATER) SOLUTION [DIVISION 5 LABS, INC.]

Do not use

Stop use and consult a doctor if you experience

Keep out of reach of children

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