CEDERROTH EMERGENCY EYE WASH- water liquid
Orkla Care 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
Sodium Chloride

Label

CEDERROTH

Emergency Eye Wash

NDC 587667-725-20

NPN 90000 0001

16.9 fl oz

500ml

STERILE

500

CEDERROTH EMERGENCY EYE WASH
water liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58767-725
Route of Administration	OPHTHALMIC

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R)	WATER	0.99 mL in 1 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:58767-725-20	1 in 1 CARTON	08/23/2013	12/31/2014
1		500 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part349	08/23/2013	12/31/2014

Labeler - Orkla Care AB (354061566)

Registrant - Orkla Care AB (354061566)

Revised: 12/2017

Document Id: 603cc06c-23ba-063a-e053-2a91aa0aa202

Set id: 14a1de59-4ce4-4577-83b3-15aa25a7298f

Version: 10

Effective Time: 20171213

Orkla Care AB