SPL v1
SPL
SPL Set ID a467b487-74a1-4399-aabe-1dcc7f71b515
Route
TOPICAL
Published
Effective Date 2019-08-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bacitracin (500 [USP'U]) Neomycin (3.5 mg) Polymyxin B (10000 [USP'U]) Pramoxine (10 mg)
Inactive Ingredients
Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2019-09-02
Description

Bacitracin Zinc 500 units Neomycin Sulfate 3.5 mg Polymyxin B Sulfate 10,000 units Pramoxine HCl 10mg

Medication Information

Warnings and Precautions

For external use only

Do not use

In the eyes

If you are allergic to any of the ingredients

Over large areas of the body

Ask a doctor before use if you have

Animal bites

Serious Burns

Deep or puncture wounds

Stop use and ask a doctor if

You need to use longer than 1 week

condition persists or gets worse

rash or other allergic reaction develops

symptoms persist for more than 1 week, or clear up and occur again within a few days

Indications and Usage

First aid to help prevent infection and for temporary relief of pain in minor cuts, scrapes and burns

Dosage and Administration

Adults and childre 2 years of age and older:

  • Clean the affected area
  • Apply a small amount of this product (an amount equal to the surface of th tip of a finger) on the area 1 to 3 times daily
  • May be covered with a sterile bandage

Children under 2 years of age: ask a doctor

Description

Bacitracin Zinc 500 units Neomycin Sulfate 3.5 mg Polymyxin B Sulfate 10,000 units Pramoxine HCl 10mg

Section 50565-1

If swallowed, get medical help or contact a poison control center immediately

Section 51727-6

White Petrolatum

Section 51945-4

Section 55105-1

First aid antibiotic (Bacitracin Zinc 500 units, Neomycin Sulfate 3.5 mg, & Polymyxin B Sulfate 10,000 units)

External Analgesic (Pramoxine HCl 10mg)

Active Ingredients (in Each Gram)

Bacitracin Zinc 500 units

Neomycin Sulfate 3.5 mg

Polymyxin B Sulfate 10,000 units

Pramoxine HCl 10mg

Structured Label Content

Indications and Usage (34067-9)

First aid to help prevent infection and for temporary relief of pain in minor cuts, scrapes and burns

Dosage and Administration (34068-7)

Adults and childre 2 years of age and older:

  • Clean the affected area
  • Apply a small amount of this product (an amount equal to the surface of th tip of a finger) on the area 1 to 3 times daily
  • May be covered with a sterile bandage

Children under 2 years of age: ask a doctor

Warnings and Precautions (34071-1)

For external use only

Do not use

In the eyes

If you are allergic to any of the ingredients

Over large areas of the body

Ask a doctor before use if you have

Animal bites

Serious Burns

Deep or puncture wounds

Stop use and ask a doctor if

You need to use longer than 1 week

condition persists or gets worse

rash or other allergic reaction develops

symptoms persist for more than 1 week, or clear up and occur again within a few days

Section 50565-1 (50565-1)

If swallowed, get medical help or contact a poison control center immediately

Section 51727-6 (51727-6)

White Petrolatum

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

First aid antibiotic (Bacitracin Zinc 500 units, Neomycin Sulfate 3.5 mg, & Polymyxin B Sulfate 10,000 units)

External Analgesic (Pramoxine HCl 10mg)

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

Bacitracin Zinc 500 units

Neomycin Sulfate 3.5 mg

Polymyxin B Sulfate 10,000 units

Pramoxine HCl 10mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:51.068282 · Updated: 2026-03-14T22:55:36.629297