SPL v1
SPL
SPL Set ID 2b1f7ffc-d8ba-41d4-8b4a-d0af253435a3
Route
TOPICAL
Published
Effective Date 2012-01-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bacitracin (400 [iU]) Neomycin (5 mg) Polymyxin B (5000 [iU]) Benzalkonium (0.40 mL) Isopropyl Alcohol (70 mL) Alcohol (62 g)
Inactive Ingredients
Water Propylene Glycol Titanium Dioxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2012-01-17

Description

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

Purpose

Antimicrobial


Medication Information

Purpose

Antimicrobial

Description

LOT/EXP:                Made in CHINA



20140301

Use

    For preparation of skin before injection.

Uses

For handwashing to decrease bacteria on the skin.

Uses:

To help prevent infection in:

minor cuts;  scrapes;  burns

Section 44425-7

Flammable - keep away from fire or flame



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

Section 50566-9

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

Section 50567-7

Wipe Injection site vigorously and discard.

Section 50570-1

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

Section 51945-4

Alcohol Cleansing  Pad

Genuine First Aid LLC, Clearwater FL 33755



www.GenuineFirstAid.com



1/pouch



GENUINE FIRST AID

Warning

For external use only.

Warnings

For external use only.

Warnings>

For external use only.

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

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.

Do Not Use:

with electrocautery, in the eyes.

Active Ingredint

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

Active Ingredient





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

Other Information

Store at room temperature.

Inactive Ingredient

Purified water.

Inactive Ingredients

Propylene glycol, carbomer, titanium dioxide, purified water

Keep Out of Reach of Children

If swallowed,



get medical help or contact a Poison Control



Center right away.

Stop Use and Consult A Doctor

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


Structured Label Content

Use

    For preparation of skin before injection.

Uses

For handwashing to decrease bacteria on the skin.

Uses:

To help prevent infection in:

minor cuts;  scrapes;  burns

Description (34089-3)

LOT/EXP:                Made in CHINA



20140301

Section 44425-7 (44425-7)

Flammable - keep away from fire or flame



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

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

Wipe Injection site vigorously and discard.

Section 50570-1 (50570-1)

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

Section 51945-4 (51945-4)

Alcohol Cleansing  Pad

Genuine First Aid LLC, Clearwater FL 33755



www.GenuineFirstAid.com



1/pouch



GENUINE FIRST AID

Purpose

Antimicrobial

Warning

For external use only.

Warnings

For external use only.

Warnings>

For external use only.

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

Do Not Use (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.

Do Not Use: (Do not use:)

with electrocautery, in the eyes.

Active Ingredint

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

Active Ingredient





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

Other Information

Store at room temperature.

Inactive Ingredient

Purified water.

Inactive Ingredients

Propylene glycol, carbomer, titanium dioxide, purified water

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.

Stop Use and Consult A Doctor (Stop use and consult a doctor)

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)