Aerowash eyewash and skin-rinse solution

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 36-104F

Use at 59-86F

Keep out of direct sunlight

Inactive ingredients

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

Spl unclassified section


Manufactured for:

Aero Healthcare

Congers, NY 10989

Made in Singapore

Ingredients and appearance - Product information

Aerowash eyewash and skin-rinse solution- Purified water

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 55305-112
Route of Administration Ophthalmic

Active Ingredient/Active Moiety

Ingredient Name Strength
Water ( UNII: 059QF0KO0R)( Water - UNII: 059QF0KO0R ) 98.577 mLin 100 mL

Inactive Ingredients

Ingredient Name Code
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

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 55305-112-14 15mL in 1 VIAL, SINGLE-USE 2015/06/01
2 NDC: 55305-112-12 148mL in 1 BOTTLE, PLASTIC 2015/06/01
3 NDC: 55305-112-13 473mL in 1 BOTTLE, PLASTIC 2015/06/01
4 NDC: 55305-112-15 947mL in 1 BOTTLE, PLASTIC 2018/06/07

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph final part349 USA 2018/06/07

Labeler - Aero Healthcare( 008186174)

Package/label principal display panel