Drug Details [pdf]

EYE WASH- eye wash liquid
Total Resources International

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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Active ingredient Purpose

Purified water (99.1%)..................................... Eyewash

Eye wash

To pour - hold bottle securely, twist off top to remove
Control rate of flow by pressure on the bottle
Flush the affected eye(s) as needed
Do not touch bottle tip to eye
If necessary, continue flushing with emergency eyewash or shower.

Do not use if pack is damaged

Do not use resterilize and reuse

Topical irrigation solution

0.9% w/v Sodium Chloride

For topical irrigation of eyes, burns and wounds

0.9% w/v Sodium Chloride

Caution:

Discard any unused solution

Single use only

Store in cool dry place

Keep out of direct sunlight

Keep out of reach of children

NDC# 55550-500-20

EYE WASH

Topical irrigation solution 0.9% w/v Sodium Chloride

For topical irrigation of eyes, burns and wounds

CAUTION:

DISCARD ANY UNUSED SOLUTION

SINGLE USE ONLY

DO NOT USE IF PACK IS DAMAGED

DO NOT RESTERILIZE AND REUSE

NOT FOR INJECTION

FOR EXTERNAL USE ONLY

STORE IN COOL DRY PLACE

KEEP OUT OF DIRECT SUNLIGHT

KEEP OUT OF REACH OF CHILDREN

20 ml

Made in China

MANUFACTURED FOR:

Total Resources Intenational, Walnut CA 91789. USA

2e0cf57a-90fd-6e5a-e054-00144ff88e88

EYE WASH
eye wash liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55550-500
Route of Administration	OPHTHALMIC

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R)	WATER	99.1 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
SODIUM CHLORITE (UNII: G538EBV4VF)

Product Characteristics
Color	white (CLEAR)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 55550-500-20	20 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/16/2016	08/01/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part349	03/16/2016	08/01/2019

Labeler - Total Resources International (790160535)

Registrant - Planet (Suzhou) Medical Products Co., Ltd (528194366)

Revised: 10/2019

Document Id: 962b2c17-8896-2b06-e053-2995a90a880f

Set id: 2e0cf57a-90fd-6e5a-e054-00144ff88e88

Version: 3

Effective Time: 20191030

Drug Labeling and Warnings

Drug Details [pdf]