EYE WASH: Package Insert and Label Information

EYE WASH- water liquid
Foshan Flying Medical Products Co., Ltd.

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 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

Keep out of reach of children

NDC# 54429-0107-1

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

bottle label
(click image for full-size original)
EYE WASH
eye wash liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:54429-0107
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
WATER (WATER) WATER 99.1 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORITE
Product Characteristics
Color white (CLEAR) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54429-0107-1 20 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 09/14/2016
Labeler — Foshan Flying Medical Products Co., Ltd. (527021584)
Registrant — Foshan Flying Medical Products Co., Ltd. (527021584)
Establishment
Name Address ID/FEI Operations
Foshan Flying Medical Products Co., Ltd. 527021584 manufacture (54429-0107)

Revised: 09/2016 Foshan Flying Medical Products Co., Ltd.

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