SPL v3
SPL
SPL Set ID cae7322c-17de-0d81-e053-2a95a90a08d7
Route
TOPICAL
Published
Effective Date 2021-11-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Polymyxin B (5000 [USP'U]) Neomycin (3500 [USP'U]) Bacitracin (500 [USP'U]) Lidocaine (40 mg)
Inactive Ingredients
Petrolatum

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
OTC MONOGRAPH FINAL Active Since 2021-08-26
Description

For external use only.

Medication Information

Warnings and Precautions

For external use only.

Indications and Usage

first aid to help prevent infection and for temporary relief of pain or discomfort in minor:

• cuts

• scrapes

• burns

Dosage and Administration

• adults and children 2 years of age or older:

• 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

• children under 2 years of age: ask a doctor

Description

For external use only.

Section 50565-1

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

Section 50569-3

• deep or puncture wounds

• animal bites

• serious burns

Section 50570-1

• if you are allergic to any of the ingredients

• in the eyes

• over large areas of the body

Section 51727-6

white petrolatum

Section 51945-4

NDC:82199-530-12 28.3 g in 1 TUBE

NDC:82199-530-11 14.2 g in 1 TUBE

Section 55105-1

First aid antibiotic

External analgesic

Section 55106-9

POLYMYXIN B SULFATE;

NEOMYCIN SULFATE;

BACITRACIN ZINC;

PRAMOXINE HYDROCHLORIDE

Section 60561-8

store at 10-30°C

Structured Label Content

Indications and Usage (34067-9)

first aid to help prevent infection and for temporary relief of pain or discomfort in minor:

• cuts

• scrapes

• burns

Dosage and Administration (34068-7)

• adults and children 2 years of age or older:

• 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

• children under 2 years of age: ask a doctor

Warnings and Precautions (34071-1)

For external use only.

Section 50565-1 (50565-1)

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

Section 50569-3 (50569-3)

• deep or puncture wounds

• animal bites

• serious burns

Section 50570-1 (50570-1)

• if you are allergic to any of the ingredients

• in the eyes

• over large areas of the body

Section 51727-6 (51727-6)

white petrolatum

Section 51945-4 (51945-4)

NDC:82199-530-12 28.3 g in 1 TUBE

NDC:82199-530-11 14.2 g in 1 TUBE

Section 55105-1 (55105-1)

First aid antibiotic

External analgesic

Section 55106-9 (55106-9)

POLYMYXIN B SULFATE;

NEOMYCIN SULFATE;

BACITRACIN ZINC;

PRAMOXINE HYDROCHLORIDE

Section 60561-8 (60561-8)

store at 10-30°C

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:49.510828 · Updated: 2026-03-14T22:59:57.476249