Label: AEROWASH EYEWASH AND SKIN-RINSE- purified water solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated June 7, 2018

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  • 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

  • SPL UNCLASSIFIED SECTION

      
    Manufactured for:

    Aero Healthcare

    Congers, NY 10989

    Made in Singapore

  • Package/Label Principal Display Panel

    AEROWASH EYEWASH
  • INGREDIENTS AND APPEARANCE
    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)
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