Label: AEROWASH EYEWASH- eyewash solution liquid

  • NDC Code(s): 55305-115-10, 55305-115-11, 55305-115-12, 55305-115-13
  • Packager: Aero Healthcare US LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated April 29, 2020

If you are a consumer or patient please visit this version.

  • 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

    1 oz.

    1oz 2

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

    4 OZ

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

    16 OZ

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

    32 OZ.

  • INGREDIENTS AND APPEARANCE
    AEROWASH EYEWASH 
    eyewash solution liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55305-115
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER0.983 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BORIC ACID (UNII: R57ZHV85D4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55305-115-1030 mL in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product01/01/2020
    2NDC:55305-115-11118 mL in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product01/01/2020
    3NDC:55305-115-12473 mL in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product01/01/2020
    4NDC:55305-115-13946 mL in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product01/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02230501/01/2020
    Labeler - Aero Healthcare US LLC (008186174)
    Registrant - Aero Healthcare US LLC (008186174)