SPL v7
SPL
SPL Set ID 41f53e2e-c2bc-4bf1-a541-3bcb2cf63002
Route
OPHTHALMIC
Published
Effective Date 2025-12-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Water (98.3 mL)
Inactive Ingredients
Boric Acid Sodium Borate Sodium Chloride

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 1900-01-01
Description

Active Ingredient: Purified Water 98.3%

Medication Information

Warnings and Precautions

Warnings: For external use only

Indications and Usage

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

Dosage and Administration

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

Description

Active Ingredient: Purified Water 98.3%

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if you experience:

  • changes in vision
  • eye pain
  • condition worsens or persists
  • continued redness or irration of the eye
Section 50567-7

When using this product:

  • to avoid contamination, do not touch tip of container to any surface
  • do not reuse
  • once opened, discard
Section 50570-1

Do not use:

  • if you experience any open wounds in or near the eyes and obtain immediate medical treatment
  • if solution changes color or becomes cloudy
Section 51727-6

Inactive Ingredients: Boric Acid, Sodium Borate, Sodium Chloride

Section 51945-4

Section 55105-1

Purpose: Eyewash

Section 55106-9

Active Ingredient: Purified Water 98.3%

Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

Directions: Flush the affeced 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

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 50566-9 (50566-9)

Stop use and ask a doctor if you experience:

  • changes in vision
  • eye pain
  • condition worsens or persists
  • continued redness or irration of the eye
Section 50567-7 (50567-7)

When using this product:

  • to avoid contamination, do not touch tip of container to any surface
  • do not reuse
  • once opened, discard
Section 50570-1 (50570-1)

Do not use:

  • if you experience any open wounds in or near the eyes and obtain immediate medical treatment
  • if solution changes color or becomes cloudy
Section 51727-6 (51727-6)

Inactive Ingredients: Boric Acid, Sodium Borate, Sodium Chloride

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose: 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: 2026-02-15T12:08:00.439495 · Updated: 2026-03-14T23:12:06.957806