Otc - Active Ingredient
Active ingredient Purpose
Purified water (99.1%)..................................... Eyewash
Eye Wash
FDA Label NDC 54429-0107
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Foshan Flying Medical Products Co., Ltd. for the product Eye Wash (NDC 54429-0107). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, instructions for use, warnings, dosage & administration, indications & usage, inactive ingredient, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Eye wash
Instructions For Use
- 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.
Warnings
Do not use if pack is damaged
Do not use resterilize and reuse
Dosage & Administration
Topical irrigation solution
0.9% w/v Sodium Chloride
Indications & Usage
For topical irrigation of eyes, burns and wounds
Inactive Ingredient
0.9% w/v Sodium Chloride
Other Safety Information
Caution:
Discard any unused solution
Single use only
Storage And Handling
Store in cool dry place
Keep out of direct sunlight
Keep out of reach of children
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
Package Label.Principal Display Panel
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 (Eyewash)
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