AeroWash Eyewash - eyewash solution

Manufacturer
Aero Healthcare US LLC
Effective date
2025-02-26
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:56:13

Label at a glance#

ProductAeroWash Eyewash
Active ingredientWATER
Label structure12 sections

Dosage and administration

Flush the affected eye as needed, controlling the rate of flow of solution by pressure on the bottle.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Purified water 98.3%

PURPOSE

OTC - PURPOSE SECTION

Eyewash

WARNINGS

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • 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

OTC - WHEN USING SECTION

  • 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

OTC - ASK DOCTOR SECTION

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

Use

INDICATIONS & USAGE SECTION

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

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Flush the affected eye as needed, controlling the rate of flow of solution by pressure on the bottle.

OTHER INFORMATION

OTHER SAFETY 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

INACTIVE INGREDIENT SECTION

boric acid, sodium borate, sodium chloride

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1 oz.1 oz.

1oz 21oz 2

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

4 OZ4 OZ

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

16 OZ16 OZ

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

32 OZ.32 OZ.

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1151101water 98.3 % Ophthalmic Irrigation SolutionPSN3
1151101water 983 MG/ML Ophthalmic Irrigation SolutionSCD3
1151101water 98.3 % Ophthalmic Irrigation SolutionSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55305-115-102025-02-26C16284748780-1d6a99b39-d878-a426-e053-dadaa90af4c2AeroWash Eyewash - eyewash solution
55305-115-112025-02-26C16284748780-1d6a99b39-d878-a426-e053-dadaa90af4c2AeroWash Eyewash - eyewash solution
55305-115-122025-02-26C16284748780-1d6a99b39-d878-a426-e053-dadaa90af4c2AeroWash Eyewash - eyewash solution
55305-115-132025-02-26C16284748780-1d6a99b39-d878-a426-e053-dadaa90af4c2AeroWash Eyewash - eyewash solution
55305-115-102025-01-30C16284748780-1d6a99b39-d878-a426-e053-dadaa90af4c2AeroWash Eyewash - eyewash solution
55305-115-112025-01-30C16284748780-1d6a99b39-d878-a426-e053-dadaa90af4c2AeroWash Eyewash - eyewash solution
55305-115-122025-01-30C16284748780-1d6a99b39-d878-a426-e053-dadaa90af4c2AeroWash Eyewash - eyewash solution
55305-115-132025-01-30C16284748780-1d6a99b39-d878-a426-e053-dadaa90af4c2AeroWash Eyewash - eyewash solution
55305-115-102023-03-06C16284748780-1d6a99b39-d878-a426-e053-dadaa90af4c2AeroWash Eyewash - eyewash solution
55305-115-112023-03-06C16284748780-1d6a99b39-d878-a426-e053-dadaa90af4c2AeroWash Eyewash - eyewash solution
55305-115-122023-03-06C16284748780-1d6a99b39-d878-a426-e053-dadaa90af4c2AeroWash Eyewash - eyewash solution
55305-115-132023-03-06C16284748780-1d6a99b39-d878-a426-e053-dadaa90af4c2AeroWash Eyewash - eyewash solution
55305-115-102022-01-28C16284748780-1d6a99b39-d878-a426-e053-dadaa90af4c2AeroWash Eyewash - eyewash solution
55305-115-112022-01-28C16284748780-1d6a99b39-d878-a426-e053-dadaa90af4c2AeroWash Eyewash - eyewash solution
55305-115-122022-01-28C16284748780-1d6a99b39-d878-a426-e053-dadaa90af4c2AeroWash Eyewash - eyewash solution
55305-115-132022-01-28C16284748780-1d6a99b39-d878-a426-e053-dadaa90af4c2AeroWash Eyewash - eyewash solution

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55305-115-10AeroWash Eyewash30 mL in 1 BOTTLE, UNIT-DOSELIQUID303
55305-115-11AeroWash Eyewash118 mL in 1 BOTTLE, UNIT-DOSELIQUID1183
55305-115-12AeroWash Eyewash473 mL in 1 BOTTLE, UNIT-DOSELIQUID4733
55305-115-13AeroWash Eyewash946 mL in 1 BOTTLE, UNIT-DOSELIQUID9463

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55305-115AEROWASH EYEWASH (EYEWASH SOLUTION) LIQUID [AERO HEALTHCARE US LLC]3Current NDC, Legacy NDC, 4 package rows20250228_a477de08-4301-0ee5-e053-2995a90af79d.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55305-11555305-115-10, 55305-115-11, 55305-115-12, 55305-115-13

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Source Document#

Source XML · Source PDF

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N022305-001PUR-WASHPURIFIED WATER98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-01

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-0184e616aacf4f…
2026-08-18 06:07:402026-07N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-01caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-01d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-0179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-01301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-011e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-018072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-015c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-015d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-014b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-0174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-01bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-01782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-0187673890dc5c…
2021-03-12 10:30 UTC2021-03N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-015aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-018869cabd3fbd…
2020-11-12 02:37 UTC2020-11N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-01c0c555d07b60…
2019-12-14 00:12 UTC2019-12N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-013f01610625f2…
2019-09-15 20:21 UTC2019-09N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-01b00525d2431f…
2019-07-19 19:46 UTC2019-07N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-01ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-016a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-011c564ffb4f44…
2023-12-20 04:57 UTC2023-12N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-01ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-01a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-019b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-01a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-013f0d92c62455…
2023-05-13 08:27 UTC2023-05N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-01053a50430f4f…
2023-01-26 05:58 UTC2023-01N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-013bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-013a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-01f41ea6bd6efb…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AeroWash EyewashEYEWASH SOLUTIONAero Healthcare US LLCa477de08-4301-0ee5-e053-2995a90af79d2025-02-26WarningsExact identifier
ndc (package): 55305-115-10
ndc (package): 55305-115-13
ndc (package): 55305-115-12
ndc (package): 55305-115-11
ndc (product): 55305-115
ndc11 (package): 55305011512
ndc11 (package): 55305011511
ndc11 (package): 55305011510
ndc11 (package): 55305011513
spl id: 2f179d38-236f-6d3f-e063-6294a90a6867
spl set id: a477de08-4301-0ee5-e053-2995a90af79d

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.