Genuine Hand Sanitizer
FDA Label NDC 52124-2906

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 Genuine Hand Sanitizer (NDC 52124-2906). 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 active ingredient, use, warnings, storage and handling, do not use:, otc - stop use, keep out of reach of children, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient



Isopropyl Alcohol, 70% v/v...............        Purpose: Antiseptic

Bacitracin Zinc 400 units

Neomycin Sulfate 5mg ( equivalent to 3.5 mg Neomycin base)

Polymyxin B Sulfate 5000 units

Ethyl Alcohol 62%

Use

    For preparation of skin before injection.

For Professional and Hospital use.  Helps prevent infection.  Antiseptic cleansing of face, hands and body without soap and water.

Warnings

For external use only.

For external use only.

Flammable

Storage And Handling

Flammable - keep away from fire or flame

Store at room temperature 15-30 degree Celsius (59-86 degree Fahrenheit)

Do Not Use:

with electrocautery, in the eyes.

Otc - Stop Use

Stop use if irritation and redness develop. If condition persists for more than 72 hours, consult your doctor.

Stop use if unusual redness, swelling or other symptoms occur. Consult a physician immediately.

Keep Out Of Reach Of Children

If swallowed,

get medical help or contact a Poison Control

Center right away.

If ingested, contact a Poison

Control Center right away.

If swallowed, get medical help or contact a Poison Control Center right away.

If swallowed, get medical help or contact a Poison Control Center right away.

Otc - When Using

Wipe Injection site vigorously and discard.

Directions: Tear open packet, unfold towelette and use to cleanse desired skin area.  Discard towelette appropriately after single use.


Inactive Ingredient

Purified water.

Purified water


Description

LOT/EXP:                Made in CHINA

20140301

LOT/EXP:                           Made in CHINA

20130301

Package Label.Principal Display Panel

Alcohol Cleansing  Pad
Genuine First Aid LLC, Clearwater FL 33755

www.GenuineFirstAid.com

1/pouch

GENUINE FIRST AID

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.

Genuine Hand Sanitizer

Instant Gel

Antiseptic Handwash with Vitamin E and Aloe

Kills 99.9% of germs without water

Active Ingredient:

Ethyl alcohol 62%

Net Wt 0.9g (1/32oz)

Antiseptic Towelette

Genuine First Aid LLC, Clearwater FL 33755

www.GenuineFirstAid.com

1/pouch

GENUINE FIRST AID

Antiseptictowelette (Antiseptictowelette)

Antiseptictowelette (Antiseptictowelette)

Genuinetripleantibiotic (Tripleantibiotic)

Genuinetripleantibiotic (Tripleantibiotic)

Alcoholcleansingpad (Alcoholcleansingpad)

Alcoholcleansingpad (Alcoholcleansingpad)

Genuine Hand Sanitizer Individual (Genuinehs)

Genuine Hand Sanitizer Individual (Genuinehs)

Uses:

To help prevent infection in:
minor cuts;  scrapes;  burns

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.

in the eyes. In case of contact, rinse eyes thoroughly with water.

Stop Use And Consult A Doctor

if the condition persists or gets worse;  a rash or other allergic reaction develops

If irritation and redness develop and persist for more than 72 hours

Directions

Cclean 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

Empty contents into palm. Rub hands until gel dissipates. Recommended for repeated use.

Other Information

Store at room temperature.

Active Ingredint

Benzalkonium Chloride 0.40%..........   Purpose: First Aid Antiseptic

Warning

For external use only.

Otc - Do Not Use

Do not use in the eyes or over large areas of the body.

Purpose

Antimicrobial

Uses

For handwashing to decrease bacteria on the skin.

Inactive Ingredients

Propylene glycol, carbomer, titanium dioxide, purified water

* Please review the disclaimer below.