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SPL v7
SPL
SPL Set ID 3b5d07c6-bda2-4bc7-89b8-88280d11ed74
Route
TOPICAL
Published
Effective Date 2018-02-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bacitracin (400 [iU]) Neomycin (3.5 mg) Polymyxin B (5000 [iU]) Benzalkonium (1.3 mg) Isopropyl Alcohol (5 mg) Benzocaine (700 mg) Alcohol (0.13 g)
Inactive Ingredients
Mineral Oil Petrolatum Water Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-02-08 Until 2025-12-31

Description

Bacitracin zinc (bacitracin 400 units) Neomycin sulfate (neomycin 3.5 mg) Polymyxin B sulfate (polymyxin B 5,000 units)

Purpose

First aid antibiotic


Medication Information

Purpose

First aid antibiotic

Description

Bacitracin zinc (bacitracin 400 units) Neomycin sulfate (neomycin 3.5 mg) Polymyxin B sulfate (polymyxin B 5,000 units)

Use
  • First aid to help prevent infection in minor cuts, scrapes, and burns.
Use:

For preparation of the skin before injection.

Uses
  • First aid to help prevent infection in minor cuts, scrapes, and burns.
  • For the temporary relief of pain and itching associated with minor burns, minor cuts, and scrapes.
Purpose:

First Aid Antiseptic

Stop Use

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

Warnings

For external use only.

Warnings:

For external use only.

Flammable: keep away from fire or flame.

Directions

• Clean the affected area. • Apply a 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 the eyes • over large areas of the body • if you are allergic to any of the ingredients

• longer than 1 week unless directed by a doctor.

Directions:

Wipe injection site vigorously and discard.

Do Not Use:

with electrocautery, in the eyes

Other Information

Store at room temperature

Package Labeling:

Active Ingredient:

Benzalkonium Chloride 0.13%

Active Ingredient:

Isopropyl Alcohol, 70% v/v

Active Ingredients

Benzalkonium chloride 0.13%

Lidocaine hydrochloride 0.5

Antiseptic Towelette

Inactive Ingredient:

Purified water.

Inactive Ingredients

Mineral Oil, petrolatum, purified water

other Information

Store at room temperature

Alcohol Cleansing Pad

Inactive Ingredients:

Purified water.

Insect Sting Relief Pad

Stop Use and Ask 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.

Active Ingredients (in Each Gram)

Bacitracin zinc (bacitracin 400 units)

Neomycin sulfate (neomycin 3.5 mg)

Polymyxin B sulfate (polymyxin B 5,000 units)

Ask A Doctor Before Use If You Have

• deep or puncture wounds • animal bites • serious burns.

First Aid Antibiotic Ointment, 0.9g

First Aid Antiseptic Pain Relieving Cream, 0.9g


Structured Label Content

Use
  • First aid to help prevent infection in minor cuts, scrapes, and burns.
Use:

For preparation of the skin before injection.

Uses
  • First aid to help prevent infection in minor cuts, scrapes, and burns.
  • For the temporary relief of pain and itching associated with minor burns, minor cuts, and scrapes.
Purpose

First aid antibiotic

Purpose:

First Aid Antiseptic

Stop Use (Stop use)

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

Warnings

For external use only.

Warnings:

For external use only.

Flammable: keep away from fire or flame.

Directions

• Clean the affected area. • Apply a 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)

• Do not use • in the eyes • over large areas of the body • if you are allergic to any of the ingredients

• longer than 1 week unless directed by a doctor.

Directions:

Wipe injection site vigorously and discard.

Do Not Use: (Do not use:)

with electrocautery, in the eyes

Other Information (Other information)

Store at room temperature

Package Labeling:

Active Ingredient:

Benzalkonium Chloride 0.13%

Active Ingredient: (Active ingredient:)

Isopropyl Alcohol, 70% v/v

Active Ingredients (Active ingredients)

Benzalkonium chloride 0.13%

Lidocaine hydrochloride 0.5

Antiseptic Towelette

Inactive Ingredient: (Inactive ingredient:)

Purified water.

Inactive Ingredients (Inactive ingredients)

Mineral Oil, petrolatum, purified water

other Information (Other information)

Store at room temperature

Alcohol Cleansing Pad

Inactive Ingredients:

Purified water.

Insect Sting Relief Pad

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

• the condition persists or gets worse • a rash or other allergic reaction develops.

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.

Active Ingredients (in Each Gram) (Active ingredients (in each gram))

Bacitracin zinc (bacitracin 400 units)

Neomycin sulfate (neomycin 3.5 mg)

Polymyxin B sulfate (polymyxin B 5,000 units)

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

• deep or puncture wounds • animal bites • serious burns.

First Aid Antibiotic Ointment, 0.9g

First Aid Antiseptic Pain Relieving Cream, 0.9g


Advanced Ingredient Data


Raw Label Data

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