Otc - Active Ingredient
Active Ingredient: Purpose
Benzalkonium Chloride 0.40%......First Aid Antiseptic
Active Ingredient:
Purified Water USP...q.s.
Medium Cuts And Scratches
FDA Label NDC 52124-0117
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Genuine First Aid Llc for the product Medium Cuts And Scratches (NDC 52124-0117). 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, warnings, otc - keep out of reach of children, otc - stop use, otc - do not use, otc - when using, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Use: For Professional and Hospital use. Helps prevent infection. Antiseptic cleansing of face, hands and body without soap and water.
Uses:
For flushing or irrigating the eyes to
remove loose foreign material, air pollutants,
or chlorinated water.
Warnings
Warning: For external use only.
Warning:
If you experience eye pain, changes in vision, continued redness or irritation of the eye,
or if the condition worsens or persists for more than 72 hours, discontinue use and consult a doctor.
Do not use if solution changes color or becomes cloudy.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children: If swallowed, get medical help or contact a Poison Control Center right away.
Otc - Stop Use
Stop use if unusual redness, swelling or other symptoms occur. Consult a physician immediately.
Otc - Do Not Use
Do not use in the eyes or over large areas of the body.
Otc - When Using
Directions: Tear open packet, unfold towelette and use to cleanse desired skin area. Discard towelette appropriately after single use.
Inactive Ingredient
Inactive Ingredient: Purified water
Inactive Ingredients:
Sodium Chloride USP 44mg
Monobasic Sodium Phosphate USP 18mg
Sodium Phosphate Dibasic USP 111mg
Edetate Disodium USP 10mg
Benzalkonium Chloride 0.5mg
NF (as preservative)
Description
LOT/EXP: Made in CHINA
20130301
Code No.: GUJ/DRUG/G/1080
Batch No.:
Mfg Date:
Exp: Date:
Package Label.Principal Display Panel
Antiseptic Towelette
Genuine First Aid LLC, Clearwater FL 33755
www.GenuineFirstAid.com
1/pouch
GENUINE FIRST AID
Antiseptictowelette (Antiseptictowelette)
10ml
Sterile Isotonic Buffered Genuine
Eyewash
For single use only
Eyewash10ml (Genuineeyewash)
Medium Cuts, Burns and Severe Bleeding
5 Antiseptic Towelette
2 Sterile Gauge Pad 2"x2"
2 Sterile Gauge Pad 3"x3"
2 Sterile Gauge Pad 4"x4"
1 Roller Gauge Bandage 2"x4.1 yds.
1 Sterile Eye Pad
1 Sterile Eye Wash 10ml
2 Butterfly Wound Closures
Manufactured in China for:
Genuine First Aid LLC.
600 Cleveland Street
Suite 400
Clearwater FL 33755
www.GenuineFirstAid.com
GENUINE FIRST AID
Copyright 2009 Genuine First Aid LLC. All rights reserved.
Medium Cuts And Burns (Mediumcuts)
Storage And Handling
Store in a cool place. For irrigation only.
Discard unused portion of the solution.
Not for injection.
Dosage & Administration
Directions
Remove contacts before using.
Twist top to remove.
Flush the affected area as needed. Control
Rate of flow by pressure on the bottle. Do not touch
tip of the container to any surface. Do not reuse.
If necessary continue flushing with emergency eyewash or shower.
Discard bottle after use.
* Please review the disclaimer below.
