Refill 2

Refill 2
SPL v9
SPL
SPL Set ID 45dde3f0-546c-4ec5-beb0-c3d0432f4983
Route
TOPICAL
Published
Effective Date 2016-08-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.13 g) Neomycin (3.5 mg) Polymyxin B (5000 [iU]) Bacitracin (400 [iU])
Inactive Ingredients
Water Mineral Oil Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-08-10
Description

Benzalkonium Chloride 0.13%

Purpose

First Aid Antiseptic

Medication Information

Purpose

First aid antibiotic

Description

Benzalkonium Chloride 0.13%

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

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

Purpose:

First Aid Antiseptic

Warnings

For external use only

Warnings:

For external use only.

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

• in the eyes • over large areas of the body • if you are allergic to any of the ingredient • longer than 1 week unless directed by a doctor.

Directions:

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

Do Not Use:

In the eyes, or over large areas of the body.

Active Ingredient:

Benzalkonium Chloride 0.13%

Inactive Ingredient:

Purified water.

Inactive Ingredients

Mineral oil, petrolatum, purified water

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. If unusual redness, swelling or other symptoms occur, consult a physician immediately.

Active Ingredients (in Each Gram)

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



Refill 2 (49687 0016 0) Labeling:

Ask A Doctor Before Use If You Have

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

Antibiotic Application (49687 0013 0) Labeling:

Antiseptic Towelettes (49687 0016 0) Labeling:

Structured Label Content

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

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

Purpose

First aid antibiotic

Purpose:

First Aid Antiseptic

Warnings

For external use only

Warnings:

For external use only.

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 ingredient • longer than 1 week unless directed by a doctor.

Directions:

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

Do Not Use: (Do not use:)

In the eyes, or over large areas of the body.

Active Ingredient:

Benzalkonium Chloride 0.13%

Inactive Ingredient: (Inactive ingredient:)

Purified water.

Inactive Ingredients (Inactive ingredients)

Mineral oil, petrolatum, purified water

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. If unusual redness, swelling or other symptoms occur, consult a physician immediately.

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

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



Refill 2 (49687 0016 0) Labeling: (Refill 2 (49687-0016-0) Labeling:)

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

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

Antibiotic Application (49687 0013 0) Labeling: (Antibiotic Application (49687-0013-0) Labeling:)

Antiseptic Towelettes (49687 0016 0) Labeling: (Antiseptic Towelettes (49687-0016-0) Labeling:)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:05:20.175071 · Updated: 2026-03-14T23:06:59.037711