Buffered Eye-Lert: Package Insert and Label Information

BUFFERED EYE-LERT — water liquid
North Safety Products

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%

Purpose

Emergency eyewash and skin flush

Uses

for flushing the eye and skin to reduce chances of severe injury caused by acid, alkali or particulate contamination.

Warnings

For external use only

Do not use

  • for injection
  • in intraocular surgery
  • internally
  • if solution changes color or becomes cloudy

When using this product

  • avoid contamination, do not touch tip of container to any surface
  • do not reuse
  • once opened, discard
  • obtain immediate medical treatment for all open wounds in or near the eyes

Ask doctor if you have

  • eye pain
  • changes in vision
  • redness or irritation of the eye after use
  • an injury caused by an alkai
  • condition worsens or persists

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

Directions

  • do not dilute solution or reuse bottle
  • hold container a few inches above the eye or skin
  • control flow of solution by pressure on bottle
  • flush affected area as needed a minimum of 20 minutes

Other information

  • tamper evident: do not use if twist off top is broken or missing
  • not for use as a contact lens solution
  • twist cap to open
  • use before expiration date marked on bottle
  • store at room temperature, 15o to 30o C (59o to 86o)

Inactive ingredients

benzalkonium chloride, edetate disodium dihydrate, sodium chloride, sodium phosphate dibasic heptahydrate, sodium phosphate monobasic monohydrate

Questions

Questions or comments? Call toll free number 1-800-130-4110

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BUFFERED EYE-LERT
water liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0498-0160
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
WATER (WATER) WATER 98 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE
EDETATE DISODIUM
BENZALKONIUM CHLORIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0498-0160-16 473 mL in 1 BOTTLE, PLASTIC None
2 NDC:0498-0160-38 946 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part349 06/06/2010
Labeler — North Safety Products (059980441)
Registrant — North Safety Products (059980441)
Establishment
Name Address ID/FEI Operations
North Safety Products 059980441 manufacture

Revised: 07/2010 North Safety Products

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