kollourion eyesalve eyewash

kollourion eyesalve eyewash
SPL v8
SPL
SPL Set ID b56d2ab9-169b-b490-e053-2a95a90a80b3
Route
ophthalmic
Published
Effective Date 2015-01-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
water (929 g)
Inactive Ingredients
sodium chloride sodium borate boric acid

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2020-12-01
Description

Active Ingredient Purified Water 98.3%

Medication Information

Warnings and Precautions

Warnings

For external use only

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

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

  • side effects occur. You may report side effects to FDA at 1-800-FDA-1088.
  • continued redness or irritation of the eye
  • condition worsens or persists
  • eye pain
  • changes in vision

Active Ingredient

Active Ingredient

Purified Water 98.3%

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 affected 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 51727-6

Inactive ingredients

boric acid, sodium borate, sodium chloride

Section 51945-4

Section 53413-1

Call 1-973-568-3361 9am to 5pm EST

Section 55105-1

Purpose

Eyewash

Section 60561-8

Other information

  • 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

Structured Label Content

Warnings and Precautions (34071-1)

Warnings

For external use only

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

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

  • side effects occur. You may report side effects to FDA at 1-800-FDA-1088.
  • continued redness or irritation of the eye
  • condition worsens or persists
  • eye pain
  • changes in vision

Active Ingredient (55106-9)

Active Ingredient

Purified Water 98.3%

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 affected eye as needed, controlling the rate of flow of solution by pressure on the bottle
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

boric acid, sodium borate, sodium chloride

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Call 1-973-568-3361 9am to 5pm EST

Section 55105-1 (55105-1)

Purpose

Eyewash

Section 60561-8 (60561-8)

Other information

  • 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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:06.804612 · Updated: 2026-03-14T23:11:56.566307