Eyewash

Manufacturer
MWI | Akorn Operating Company LLC | Niagara Pharmaceuticals, Inc.
Effective date
2020-10-26
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 23:09:47

Label at a glance#

ProductEyewash
Active ingredientWATER
Label structure10 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#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Purified water 98.3%

Purpose

OTC - PURPOSE SECTION

Eyewash

Use

INDICATIONS & USAGE SECTION

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

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

OTC - STOP USE SECTION

Stop use and ask a doctor if you experience

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. 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

SPL UNCLASSIFIED SECTION

  • 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

Questions ?

OTC - QUESTIONS SECTION

Call 888-628-0581

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Container Label:

NDC 13985-609-04

Ophthalmic

Solution

Eyewash

Purified Water, 98.3%

STERILE SOLUTION

Single Use

APEXA logo

AP 704011

4 fl.oz. (118 mL)

Principal Display Panel Text for Container Label
Principal Display Panel Text for Container Label

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
WaterACTIVE INGREDIENT059QF0KO0R1
WaterACTIVE MOIETY059QF0KO0R1
Boric AcidINACTIVE INGREDIENTR57ZHV85D41
Sodium BorateINACTIVE INGREDIENT91MBZ8H3QO1
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8X1

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
13985-60913985-609-04

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

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 3 · 157 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XLIQUID / INTRAVENOUS6320 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XGEL / OPHTHALMIC0.9 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XSOLUTION / IONTOPHORESIS0.6 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION / PERIDURAL8.07 mgExact identifier — unii candidate
134 equally ranked IID candidates
Boric AcidBORIC ACIDR57ZHV85D4INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS0.53 %w/vExact identifier — unii candidate
17 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XDROPS / OPHTHALMIC0.08 %w/wExact identifier — unii candidate
134 equally ranked IID candidates
Boric AcidBORIC ACIDR57ZHV85D4SUSPENSION/ DROPS / TOPICAL0.3 %w/vExact identifier — unii candidate
17 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XSOLUTION/ DROPS / TOPICAL0.86 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION, SUSPENSION / SUBCUTANEOUS0.8 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS2922 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XSHAMPOO / TOPICAL150 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION / EPIDURAL648 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION, POWDER, FOR SOLUTION / INTRA-ARTERIAL1.35 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION / INTRABURSAL9 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XTABLET, FILM COATED / ORAL100 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION, POWDER, FOR SUSPENSION / SUBCUTANEOUSNAExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XSUPPOSITORY / RECTAL140 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / PARENTERAL210 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XSUSPENSION / OPHTHALMIC10 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR226 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XTABLET, CHEWABLE / ORAL20 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium BorateSODIUM BORATE91MBZ8H3QOSUSPENSION/ DROPS / OPHTHALMIC0.03 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XPOWDER, DENTIFRICE / DENTAL0.03 mg/mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION, CONCENTRATE / SUBCUTANEOUS0.86 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION / INTRATUMOR1.2 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XSYSTEM / IONTOPHORESIS3.1 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XCREAM / TOPICAL0.4 %w/wExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / SUBMUCOSAL16 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XSYRUP / ORAL40 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XSUSPENSION/ DROPS / TOPICAL0.23 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XTABLET, COATED / ORAL54.7 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION, EMULSION / INTRAVENOUS0.62 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XTABLET, EXTENDED RELEASE / ORAL335.1 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION, SUSPENSION / INTRAVITREAL6 mgExact identifier — unii candidate
134 equally ranked IID candidates
Boric AcidBORIC ACIDR57ZHV85D4SUSPENSION / AURICULAR (OTIC)0.6 %w/vExact identifier — unii candidate
17 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS1800 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XTABLET, DELAYED RELEASE / ORAL97 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION / DENTAL0.4 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / EPIDURAL3535 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS0.68 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
Sodium BorateSODIUM BORATE91MBZ8H3QOEMULSION / OPHTHALMIC0.11 %w/vExact identifier — unii candidate
6 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / INTRAMUSCULAR1486 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / INTRAVESICAL351 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XPOWDER, FOR SUSPENSION / ENDOTRACHEAL46.76 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION, SUSPENSION / INTRAMUSCULAR26 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XSUSPENSION / RESPIRATORY (INHALATION)43 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XSUSPENSION / SUBCUTANEOUS0.8 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / SUBARACHNOID0.9 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XJELLY / NASALNAExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION, SUSPENSION / SOFT TISSUE26 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION / INTRACARDIAC70 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XGEL / TOPICAL0.18 %w/wExact identifier — unii candidate
134 equally ranked IID candidates
Boric AcidBORIC ACIDR57ZHV85D4EMULSION / OPHTHALMIC0.3 %w/vExact identifier — unii candidate
17 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION / INTRAVENOUS28773 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium BorateSODIUM BORATE91MBZ8H3QOSOLUTION / AURICULAR (OTIC)0.3 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION / INTRATHECAL9 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XPOWDER / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION / INTRAVITREAL10 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
Boric AcidBORIC ACIDR57ZHV85D4SHAMPOO / TOPICAL2 %w/wExact identifier — unii candidate
17 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XCAPSULE / ORAL6 mgExact identifier — unii candidate
134 equally ranked IID candidates

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
244969aa-7b28-750c-e063-6394a90ad15d1fa0cc05-37ce-4d61-8060-fd89a5d449d22024-10-12WarningsExact identifier
spl set id: 1fa0cc05-37ce-4d61-8060-fd89a5d449d2

Reported adverse events (FAERS/openFDA)#

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