AEROWASH EYEWASH AND SKIN-RINSE- purified water solution 
Aero Healthcare

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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AEROWASH EYEWASH

Active ingredient

Purified water USP

98.577% w/v

Purpose

Eyewash

Use

Use for flushing the eye to remove loose foreign material.

Warnings

For External Use Only

To avoid contamination, do not touch tip of container to any surface.

Do not reuse.

Once opened, discard.

If you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists, consult a doctor.

Obtain immediate medical treatment for all open wounds in or near the eyes.

If solution changes color or becomes cloudy do not use nor, if twist-off Tamper Evident top is broken or missing.

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 at 36°-104°F

Use at 59°-86°F

Keep out of direct sunlight

Inactive ingredients

disodium EDTA
polyhexanide
sodium chloride
sodium hydroxide
sodium phosphate, dibasic
sodium phosphate, monobasic

  
Manufactured for:

Aero Healthcare

Congers, NY 10989

Made in Singapore

Package/Label Principal Display Panel

AEROWASH EYEWASH
AEROWASH EYEWASH AND SKIN-RINSE 
purified water solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55305-112
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER98.577 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
POLIHEXANIDE (UNII: 322U039GMF)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATE (UNII: E1W4N241FO)  
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55305-112-1415 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product06/01/2015
2NDC:55305-112-12148 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2015
3NDC:55305-112-13473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2015
4NDC:55305-112-15947 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/07/2018
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34905/01/2015
Labeler - Aero Healthcare (008186174)

Revised: 6/2018
Document Id: 6e120024-473b-73af-e053-2a91aa0a42a6
Set id: 491f8433-bcf2-4545-8974-3094fa5b4a29
Version: 2
Effective Time: 20180607
 
Aero Healthcare