Eye Clean: Package Insert and Label Information

EYE CLEAN- water liquid
HART Health

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active Ingredient: Purified Water 98.3%

Purpose: Eyewash

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

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 you experience:

  • changes in vision
  • eye pain
  • condition worsens or persists
  • continued redness or irration of the eye

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

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

Inactive Ingredients: Boric Acid, Sodium Borate, Sodium Chloride

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EYE CLEAN
eye wash liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50332-0201
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
WATER (WATER) WATER 98.3 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
BORIC ACID
SODIUM BORATE
SODIUM CHLORIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50332-0201-3 30 mL in 1 BOTTLE None
2 NDC:50332-0201-1 118 mL in 1 BOTTLE None
3 NDC:50332-0201-4 236 mL in 1 BOTTLE None
4 NDC:50332-0201-6 473 mL in 1 BOTTLE None
5 NDC:50332-0201-8 946 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part349 01/01/1900
Labeler — HART Health (069560969)
Registrant — Niagara Pharmaceuticals, Inc. (205477792)
Establishment
Name Address ID/FEI Operations
Niagara Pharmaceuticals, Inc. 205477792 manufacture (50332-0201)

Revised: 11/2019 HART Health

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