CEDERROTH EMERGENCY EYE WASH- water liquid
Cederroth AB

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.

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CEDERROTH Emergency Eye Wash

Drug Facts

Active Ingredient

Purified water 99%

Purpose

Irrigation of eye

Use

For flushing the eye 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 become cloudy

Ask a doctor if you have

eye pain
changes in vision
redness or irritation of the eye after use
an injury caused by an alkali

To avoid contamination, do not touch tip of container to any surface. Do not reuse. Once opened, discard.

Keep out of reach of children

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

Directions

do not dilute solution or reuse bottle
use only unopened bottle
remove green cap (by twisting in either direction)
avoid contamination of rim of eyecup
hold the eye cup to the eye
tilt head backward
open eyelids wide
thoroughly bathe eye with solution and rotate eyeball for thorough washing
allow solution to flow away from eye
flush affected area for a minimum of 20 minutes
continue flushing with water if necessary
obtain medical treatment, especially after exposure to acid or alkali

Other information

Store at 35-104°F (2-40°C). Use at 59-86°F (15-30°C)

Inactive Ingredients

Boric acid, Sodium borate decahydrate, Sodium chloride.

CEDERROTH Emergency Eye Wash 235ml (58767-722-11)

CEDERROTH EMERGENCY EYE WASH
water liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58767-722
Route of Administration	OPHTHALMIC

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R)	WATER	99 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
BORIC ACID (UNII: R57ZHV85D4)
SODIUM BORATE (UNII: 91MBZ8H3QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58767-722-11	235 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	03/13/2014	12/31/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part349	03/13/2014	12/31/2014

Labeler - Cederroth AB (354061566)

Registrant - Cederroth AB (354061566)

Name	Address	ID/FEI	Business Operations
Establishment
Unite de Fabrication de Medicaments SA		552484305	manufacture(58767-722)

Revised: 12/2017

Document Id: 603ccb20-d24e-08f5-e053-2991aa0af273

Set id: ae1b2ac0-211f-4fd9-9fa6-b7131b2b61ce

Version: 3

Effective Time: 20171213

Cederroth AB