SPL v1
SPL
SPL Set ID 2ea26d96-704b-17bb-e063-6394a90a7e27
Route
OPHTHALMIC
Published
Effective Date 2025-02-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chloride Ion (9 mg)
Inactive Ingredients
Sodium Borate Calcium Chloride Magnesium Chloride Potassium Chloride Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-02-27

Description

Sodium chloride 0.9% (W/V)

Purpose

Lubricant (Artificial Tears)


Medication Information

Purpose

Lubricant (Artificial Tears)

Description

Sodium chloride 0.9% (W/V)

Uses

- Relieves dryness and irritation of the eye

- Provides temporary relief from discomfort due to minor eye irritations or exposure to wind or sun

- Helps protect against further eye irritation

Warnings

For external use only

- Do not use if solution changes color or becomes cloudy

- Do not touch the tip of the container to any surface to avoid contamination

Directions

- To open, twist cap to remove

- Instill 1 to 2 drops in the affected eye(s) as needed

- Discard any unused portion

Package Label

Active Ingredient

Sodium chloride 0.9% (W/V)

Other Information

- Store at 15-30°C (59-86°F)

- Do not use if tamper-evident seal is broken or missing

Inactive Ingredients

Purified water, sodium borate, potassium chloride, calcium chloride, magnesium chloride

Stop Use and Ask A Doctor If:

- You experience eye pain, changes in vision, continued redness, or irritation of the eye

- Condition worsens or persists for more than 72 hours

Keep Out of Reach of Children.

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


Structured Label Content

Uses

- Relieves dryness and irritation of the eye

- Provides temporary relief from discomfort due to minor eye irritations or exposure to wind or sun

- Helps protect against further eye irritation

Purpose

Lubricant (Artificial Tears)

Warnings

For external use only

- Do not use if solution changes color or becomes cloudy

- Do not touch the tip of the container to any surface to avoid contamination

Directions

- To open, twist cap to remove

- Instill 1 to 2 drops in the affected eye(s) as needed

- Discard any unused portion

Package Label

Active Ingredient

Sodium chloride 0.9% (W/V)

Other Information

- Store at 15-30°C (59-86°F)

- Do not use if tamper-evident seal is broken or missing

Inactive Ingredients

Purified water, sodium borate, potassium chloride, calcium chloride, magnesium chloride

Stop Use and Ask A Doctor If: (Stop use and ask a doctor if:)

- You experience eye pain, changes in vision, continued redness, or irritation of the eye

- Condition worsens or persists for more than 72 hours

Keep Out of Reach of Children. (Keep out of reach of children.)

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


Advanced Ingredient Data


Raw Label Data

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