Pn: 32-001050-0000-h5, Ndc: 0498-0630-37: Fendall Pure Flow 1000

Pn: 32-001050-0000-h5, Ndc: 0498-0630-37: Fendall Pure Flow 1000
SPL v9
SPL
SPL Set ID afda6fc3-7615-b0be-e053-2995a90a6208
Route
OPHTHALMIC
Published
Effective Date 2020-08-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Water (98.6 L)
Inactive Ingredients
Sodium Chloride Sodium Phosphate, Monobasic, Monohydrate Sodium Phosphate, Dibasic Edetate Disodium Benzalkonium Chloride

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-12-15

Description

Purified Water 98.6%

Purpose

Emergency Eyewash


Medication Information

Purpose

Emergency Eyewash

Description

Purified Water 98.6%

Uses

For flushing or irrigating the eye to reduce chances of severe injury caused by acid, alkali, or particulate contamination

Warnings

For external use only

Directions
  • pull handle on the activation door to initiate flow
  • lower head into flow for 15 minutes
  • if necessary continue flushing with emergency eyewash or shower
  • do not reuse
  • discard cartridge after use
Do Not Use
  • if solution changes color or gets cloud
  • in open wounds in or near eyes
  • with contact lenses
Questions?

USA: 800-430-5490 Canada: 888-212-7233

Honeywell Safety Products USA, Inc.

855 S. Mint Street, Charlotte, NC, 28202

Active Ingredient

Purified Water 98.6%

Other Information
  • store at rom temperature, 59 o to 86 o F (15 o to 30 o C)
  • do not freeze
Inactive Ingredients

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

Principle Display Panel

Changes From Previous Version
  • Indications and Usage
  • Warnings and Precautions
Keep Out of Reach of Children

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

Stop Use and Ask A Doctor If You Have
  • changes in vision
  • eye pain
  • continued redness or irritation of the eyes or if the condition worsens or persists

Structured Label Content

Uses

For flushing or irrigating the eye to reduce chances of severe injury caused by acid, alkali, or particulate contamination

Purpose

Emergency Eyewash

Warnings

For external use only

Directions
  • pull handle on the activation door to initiate flow
  • lower head into flow for 15 minutes
  • if necessary continue flushing with emergency eyewash or shower
  • do not reuse
  • discard cartridge after use
Do Not Use (Do not use)
  • if solution changes color or gets cloud
  • in open wounds in or near eyes
  • with contact lenses
Questions?

USA: 800-430-5490 Canada: 888-212-7233

Honeywell Safety Products USA, Inc.

855 S. Mint Street, Charlotte, NC, 28202

Active Ingredient (Active ingredient)

Purified Water 98.6%

Other Information (Other information)
  • store at rom temperature, 59 o to 86 o F (15 o to 30 o C)
  • do not freeze
Inactive Ingredients (Inactive ingredients)

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

Principle Display Panel

Changes From Previous Version (Changes from previous version)
  • Indications and Usage
  • Warnings and Precautions
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

Stop Use and Ask A Doctor If You Have (Stop use and ask a doctor if you have)
  • changes in vision
  • eye pain
  • continued redness or irritation of the eyes or if the condition worsens or persists

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)