AEROWASH EYEWASH- eyewash solution liquid

AeroWash Eyewash by

Drug Labeling and Warnings

AeroWash Eyewash by is a Otc medication manufactured, distributed, or labeled by Aero Healthcare US LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Purified water 98.3%

PURPOSE

Eyewash

WARNINGS

For external use only

Do not use

• if you experience any open wounds in or near the eyes and obtain immediate medical treatment
• if solution changes color or becomes cloudy

When using this product

• to avoid contamination, do not touch tip of container to any surface
• do not reuse
• once opened, discard

Stop use and ask a doctor if you have any of the following

• changes in vision
• eye pain
• condition worsens or persists
• continued redness or irritation of the eye

Use

For cleansing the eye to help relieve irritation or burning by removing loose foreign material

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

• lot number is printed on the bottle
• store at 20° to 25° C [68° to 77° F)
• for your protection, this bottle has an imprinted white seal with black printing “TAMPER EVIDENT SEAL”
• do not use if this seal is missing or broken
• use before expiration date marked on bottle

INACTIVE INGREDIENTS

boric acid, sodium borate, sodium chloride

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 1 FL OZ (30 ML) LABEL

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 4 FL OZ (118 ML)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 16 FL OZ (473 ML)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 32 FL OZ (946 ML)

INGREDIENTS AND APPEARANCE

AEROWASH EYEWASH 
eyewash solution liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55305-115
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R)	WATER	0.983 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BORIC ACID (UNII: R57ZHV85D4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BORATE (UNII: 91MBZ8H3QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55305-115-10	30 mL in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product	01/01/2020
2	NDC: 55305-115-11	118 mL in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product	01/01/2020
3	NDC: 55305-115-12	473 mL in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product	01/01/2020
4	NDC: 55305-115-13	946 mL in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product	01/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA022305	01/01/2020

Labeler - Aero Healthcare US LLC (008186174)

Registrant - Aero Healthcare US LLC (008186174)