SPL v1
SPL
SPL Set ID d11d53d1-f960-dfe9-e053-2995a90aa681
Route
TOPICAL
Published
Effective Date 2021-11-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2021-11-18

Description

POLYMYXIN B SULFATE; NEOMYCIN SULFATE; BACITRACIN ZINC; LIDOCAINE HYDROCHLORIDE


Medication Information

Warnings and Precautions

For external use only

Indications and Usage

first aid to help prevent infection and for the 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 thearea 1 to 3 times daily

• may be covered with a sterile bandage

• children under 2 years of age: ask a doctor

Description

POLYMYXIN B SULFATE; NEOMYCIN SULFATE; BACITRACIN ZINC; LIDOCAINE HYDROCHLORIDE

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

petrolatum

Section 51945-4

NDC: 82199-531-13 14.2 g in 1 TUBE

NDC: 82199-531-14 28.3 g in 1 TUBE

Section 55105-1

First aid antibiotic

External analgesic

Section 55106-9

POLYMYXIN B SULFATE;

NEOMYCIN SULFATE;

BACITRACIN ZINC;

LIDOCAINE HYDROCHLORIDE

Section 60561-8

store at 10°C-30°C


Structured Label Content

Indications and Usage (34067-9)

first aid to help prevent infection and for the 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 thearea 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)

petrolatum

Section 51945-4 (51945-4)

NDC: 82199-531-13 14.2 g in 1 TUBE

NDC: 82199-531-14 28.3 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;

LIDOCAINE HYDROCHLORIDE

Section 60561-8 (60561-8)

store at 10°C-30°C


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)