The following Structured Product Label (SPL) was submitted to the FDA by Genuine First Aid Llc for the product Emergency Preparedness (NDC 52124-0115). 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 - stop use, otc - keep out of reach of children, dosage & administration, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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
Warnings:
For external use only
Flammable, keep away from fire or flame
Warnings:
For external use only.
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.
Stop use if unusual redness, swelling or other symptoms occur. Consult a physician immediately.
Stop use and consult a doctor : if the condition persists or gets worse; a rash or other allergic
reaction develops
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
Keep out of reach of children: If swallowed, get medical help or contact a Poison Control Center right away.Keep out of reach of children.
If ingested, contact a Poison
Control Center right away.
Directions:
Empty contents into palm. Rub hands until gel dissipates. Recommended for repeated use.Other Information: Store at 15 to 25 degree Celsius (59 to 77 degree Fahrenheit)
Other information:
Store at room temperature.
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)
Emergency Preparedness
2 Procedural Masks, 3 ply
1 Emergency Blanket 38" x 60"
1 Light Stick
4 Antiseptic Towelettes
1 Triple Antibiotic Ointment 0.9 gr
1 Hand Sanitizer 0.9 gr
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.
Emergency Preparedness Kit (Emprepkit)
Directions: 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
LOT/EXP: Made in CHINA
20130301
* Please review the disclaimer below.
