32-000509-0000-hs (0498-2501-01), And 32-000513-0000-h5 (0498-2501-01) Concentrate Products

32-000509-0000-hs (0498-2501-01), And 32-000513-0000-h5 (0498-2501-01) Concentrate Products
SPL v1
SPL
SPL Set ID 2d90c8e8-f479-3535-e063-6394a90af122
Route
OPHTHALMIC
Published
Effective Date 2025-02-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Water (92.14 L)
Inactive Ingredients
Sodium Phosphate, Monobasic, Monohydrate Sodium Phosphate, Dibasic, Anhydrous Sodium Chloride Edetate Disodium Benzalkonium Chloride

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-02-04

Description

Purified Water 92.14%


Medication Information

Warnings and Precautions

For external use only- Obtain immediate medical treatment for all open wounds in or near eyes. To avoid contamination, do not touch tip of container to any surface. Replace cap after use.

Indications and Usage

For flushing the eye to remove loose foreign material, air pollutants or chlorinated water

Description

Purified Water 92.14%

Section 50565-1

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

Section 50566-9

Changes in vision, continued redness, irritation or pain, or if the condition worsens or persist

Section 50570-1

In concentrated form

While wearing contact lenses

For injection

In intraocular sugery

Internaly

if eye is lacerated or object is imbeded

if seal is broken

Section 51727-6

Benzalkonium chloride, edetate disodium, sodium chloride, sodium phosphate dibasic, sodium phosphate monobasic

Section 51945-4

Section 53413-1

USA: 800 430-5490

Canada: 888 212-7233

Honeywell Safety Products USA, 855 S. Mint Street, Charlotte, NC 28202

Section 55105-1

Eyewash

Section 55106-9

Purified Water 92.14%

Directions

Concentrate must be diluted (1) part concentrate to (10) parts potable water before use

• Prepare sufficient quantity of constituted eyewash solution in advance of an emergency.

• Mix concentrate with potable water to prepare eyewash solution as follows:

• Determine quantity of eyewash solution required

• Follow sanitary procedures

• Wear protective eyewear and gloves

• Pour 1/3 of required amount of potable water into mixing container or eyewash unit

• Add 1/3 of required amount of concentrate to water

• Agitate or mix thoroughly

• Repeat until required amount of solution is prepared

• Properly dispose of empty bottle after use.

• Do not reuse • Keep bottle upright

• Replace solution no longer than (6) months after mixing


Structured Label Content

Indications and Usage (34067-9)

For flushing the eye to remove loose foreign material, air pollutants or chlorinated water

Warnings and Precautions (34071-1)

For external use only- Obtain immediate medical treatment for all open wounds in or near eyes. To avoid contamination, do not touch tip of container to any surface. Replace cap after use.

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Changes in vision, continued redness, irritation or pain, or if the condition worsens or persist

Section 50570-1 (50570-1)

In concentrated form

While wearing contact lenses

For injection

In intraocular sugery

Internaly

if eye is lacerated or object is imbeded

if seal is broken

Section 51727-6 (51727-6)

Benzalkonium chloride, edetate disodium, sodium chloride, sodium phosphate dibasic, sodium phosphate monobasic

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

USA: 800 430-5490

Canada: 888 212-7233

Honeywell Safety Products USA, 855 S. Mint Street, Charlotte, NC 28202

Section 55105-1 (55105-1)

Eyewash

Section 55106-9 (55106-9)

Purified Water 92.14%

Directions

Concentrate must be diluted (1) part concentrate to (10) parts potable water before use

• Prepare sufficient quantity of constituted eyewash solution in advance of an emergency.

• Mix concentrate with potable water to prepare eyewash solution as follows:

• Determine quantity of eyewash solution required

• Follow sanitary procedures

• Wear protective eyewear and gloves

• Pour 1/3 of required amount of potable water into mixing container or eyewash unit

• Add 1/3 of required amount of concentrate to water

• Agitate or mix thoroughly

• Repeat until required amount of solution is prepared

• Properly dispose of empty bottle after use.

• Do not reuse • Keep bottle upright

• Replace solution no longer than (6) months after mixing


Advanced Ingredient Data


Raw Label Data

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