cae7322c-17de-0d81-e053-2a95a90a08d7

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.

Active Ingredient

POLYMYXIN B SULFATE;

NEOMYCIN SULFATE;

BACITRACIN ZINC;

PRAMOXINE HYDROCHLORIDE

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 60561-8

store at 10-30°C

Structured Label Content

Warnings and Precautions (34071-1)

For external use only.

Active Ingredient (55106-9)

POLYMYXIN B SULFATE;

NEOMYCIN SULFATE;

BACITRACIN ZINC;

PRAMOXINE HYDROCHLORIDE

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

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 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