The following Structured Product Label (SPL) was submitted to the FDA by Genuine First Aid Llc for the product Small Cuts And Burns (NDC 52124-0116). 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 - do not use, otc - keep out of reach of children, dosage & administration, storage and handling, description, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active Ingredients:
Benzalkonium Chloride 0.13%
Lidocaine HCL 0.5%
Active Ingredient: Purpose
Benzalkonium Chloride 0.40%... First Aid Antiseptic
Active Ingredient: .........Bacitracin Zinc 400 units
Neomycin Sulfate 5mg ( equivalent to 3.5 mg Neomycin base)
Polymyxin B Sulfate 5000 units
Uses: To help prevent infection in:
minor cuts; scrapes; burns
Warning: For external use only.
Warnings:
For external use only.
Do not use: in eyes, in large quantities, over raw blistered areas,
or on deep puncture wounds, animal bites or serious burns, for more than one week
Do not use: in eyes; over large areas of the body;
If allergic to any of the ingredients; for more than one week unless directed by a physician.
Keep out of reach of children.
If ingested, contact a Poison Control Center right away.
Keep out of reach of children.
If ingested, contact a Poison
Control Center right away.
Directions: Clean affected area, Apply small amount not more than 3 times daily.
May be covered with a sterile bandage.
Other information:
Store at room temperature.
LOT/EXP: Made in CHINA
20130301
LOT/EXP: Made in CHINA
20130301
Antiseptic Towelette
Genuine First Aid LLC, Clearwater FL 33755
www.GenuineFirstAid.com
GENUINE FIRST AID
Antiseptictowelette (Antiseptictowelette)
Genuine Triple Antibiotic
First Aid Ointment
To Help Prevent Infection
Each Gram Contains:
Bacitracin Zinc 400 units
Neomycin Sulfate 5 mg
(equivalent to 3.5 mg
Neomycin base)
Polymyxin B Sulfate 5000 units
Net Wt. 0.5g ; (1/64 oz)
Manufactured in CHINA for
GENUINE FIRST AID.
Genuinetripleantibiotic (Genuinetripleantibiotic)
Small Cuts and Burns
10 Adhesive Plastic Bandages 3/4"x3"
Small Cuts And Burns (Smallcutsburns)
Stop use if unusual redness, swelling or other symptoms occur.
Stop use and consult a doctor:
if the condition persists or gets worse; a rash or other allergic reaction developsDirections: Tear open packet, unfold towelette
and use to cleanse desired skin area. Discard
towelette appropriately after single use.
Directions: clean affected area; apply small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily; may be covered with a sterile bandage
Inactive Ingredient: Purified water
* Please review the disclaimer below.
