major eye wash

major eye wash
SPL v2
SPL
SPL Set ID 9d1e36cc-01b0-44bf-8f70-26de727984d9
Route
ophthalmic
Published
Effective Date 2020-02-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
water (99.05 mL)
Inactive Ingredients
boric acid sodium borate sodium chloride hydrochloric acid edetate disodium polihexanide

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2017-05-01

Purpose

Eyewash

How Supplied

Product: 50090-3159 NDC: 50090-3159-0 118 mL in a BOTTLE / 1 in a BOX

Description

Purified water (99.05%)


Medication Information

Warnings

For external use only

Uses

washes the eye to help relieve

  • irritation
  • stinging
  • discomfort
  • itching

by removing

  • loose foreign material
  • air pollutants (smog or pollen)
  • chlorinated water
Purpose

Eyewash

Directions
  • flush the affected eye(s) as needed
  • control the rate of flow of solution by placing pressure on the bottle
Other Information
  • store at room temperature 15° - 25°C (59° - 77°F)
  • keep tightly closed
Inactive Ingredients

boric acid, sodium borate, sodium chloride, hydrochloric acid PRESERVATIVE ADDED: edetate disodium, polyhexamethylene biguanide

How Supplied

Product: 50090-3159

NDC: 50090-3159-0 118 mL in a BOTTLE / 1 in a BOX

Description

Purified water (99.05%)

Do Not Use
  • if solution changes color or becomes cloudy
Purified Water
Active Ingredient

Purified water (99.05%)

Question Or Comments?

call 1-800-616-2471

When Using An Eye Cup
  • rinse the cup with Eye Wash immediately before each use
  • avoid contamination of the rim and inside surfaces of the cup
  • fill the cup half full with Eye Wash and apply the cup to the affected eye(s), pressing tightly to prevent the escape of the liquid
  • tilt the head backward. Open eyelids wide and rotate eyeball to ensure thorough bathing with the wash.
  • rinse the cup with clean water after each use
When Using This Product
  • remove contact lenses before using
  • do not touch tip of container to any surface to avoid contamination
  • replace cap after use
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
  • you have open wounds in or near the eye. Get medical help right away.
Keep Out of Reach of Children.

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


Structured Label Content

Warnings

For external use only

Uses

washes the eye to help relieve

  • irritation
  • stinging
  • discomfort
  • itching

by removing

  • loose foreign material
  • air pollutants (smog or pollen)
  • chlorinated water
Purpose

Eyewash

Directions
  • flush the affected eye(s) as needed
  • control the rate of flow of solution by placing pressure on the bottle
Other Information (Other information)
  • store at room temperature 15° - 25°C (59° - 77°F)
  • keep tightly closed
Inactive Ingredients (Inactive ingredients)

boric acid, sodium borate, sodium chloride, hydrochloric acid PRESERVATIVE ADDED: edetate disodium, polyhexamethylene biguanide

How Supplied (HOW SUPPLIED)

Product: 50090-3159

NDC: 50090-3159-0 118 mL in a BOTTLE / 1 in a BOX

Do Not Use (Do not use)
  • if solution changes color or becomes cloudy
Purified Water (purified water)
Active Ingredient (Active ingredient)

Purified water (99.05%)

Question Or Comments? (Question or comments?)

call 1-800-616-2471

When Using An Eye Cup (When using an eye cup)
  • rinse the cup with Eye Wash immediately before each use
  • avoid contamination of the rim and inside surfaces of the cup
  • fill the cup half full with Eye Wash and apply the cup to the affected eye(s), pressing tightly to prevent the escape of the liquid
  • tilt the head backward. Open eyelids wide and rotate eyeball to ensure thorough bathing with the wash.
  • rinse the cup with clean water after each use
When Using This Product (When using this product)
  • remove contact lenses before using
  • do not touch tip of container to any surface to avoid contamination
  • replace cap after use
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
  • you have open wounds in or near the eye. Get medical help right away.
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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