SPL v4
SPL
SPL Set ID 0ebfbede-6345-4ed4-a817-49e0280d6db1
Route
OPHTHALMIC
Published
Effective Date 2017-11-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Water (983 mg)
Inactive Ingredients
Sodium Chloride

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2015-07-23
Description

Uses: fOR CLEANSING THE EYE TO HELP RELIEVE IRRITATION OR BURNING BY REMOVING LOOSE FOREIGN MATERIAL

Medication Information

Warnings and Precautions

Warnings:

For external use only. 

Do not use if: you experience any open wounds in or near the eye 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.

Indications and Usage

Uses:

fOR CLEANSING THE EYE TO HELP RELIEVE IRRITATION OR BURNING BY REMOVING LOOSE FOREIGN MATERIAL

Dosage and Administration

Directions:

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

Description

Uses: fOR CLEANSING THE EYE TO HELP RELIEVE IRRITATION OR BURNING BY REMOVING LOOSE FOREIGN MATERIAL

Section 50565-1

KEEP OUT OF REACH OF CHILDREN. iF SWALLOWED, get medical help or

contact a Poison Control Center right

away.

Section 51727-6

Inactive Ingredients:

sodium chloride

Section 51945-4

Section 53414-9

If pregnant or breast-feeding, ask a health

professional before use.

Section 55105-1

EYEWASH

Section 55106-9

ACTIVE INGREDIENT-PURIFIED WATER 98.3%

Structured Label Content

Indications and Usage (34067-9)

Uses:

fOR CLEANSING THE EYE TO HELP RELIEVE IRRITATION OR BURNING BY REMOVING LOOSE FOREIGN MATERIAL

Dosage and Administration (34068-7)

Directions:

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

Warnings and Precautions (34071-1)

Warnings:

For external use only. 

Do not use if: you experience any open wounds in or near the eye 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.

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN. iF SWALLOWED, get medical help or

contact a Poison Control Center right

away.

Section 51727-6 (51727-6)

Inactive Ingredients:

sodium chloride

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health

professional before use.

Section 55105-1 (55105-1)

EYEWASH

Section 55106-9 (55106-9)

ACTIVE INGREDIENT-PURIFIED WATER 98.3%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:26.137646 · Updated: 2026-03-14T22:54:54.026912