SPL v3
SPL
SPL Set ID bd3b8146-6271-488d-bf79-0bb659123b31
Route
TOPICAL
Published
Effective Date 2017-02-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bacitracin (0.41 g) Neomycin (0.0035 g) Polymyxin B (0.52 g)
Inactive Ingredients
Mineral Oil Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-02-22
Description

Active ingredients (in each gram) Bacitracin 400 units Neomycin 3.5 mg Polymyxin B 5,000 units

Medication Information

Warnings and Precautions

Warnings

. For external use only

Do not use

Ask a doctor before use if you have

Stop use and ask a doctor if

  • if you are allergic to any of the ingredients in this product
  • in contact with the eyes or mucous membranes
  • over large areas of the body
  • deep or puncture wounds
  • animal bites
  • serious burns
  • symptoms persist for mroe than 7 days, the condition persists or gets worse
  • symptoms clear up and then occur again within a few days
  • a rash or other allergic reaction occurs
Indications and Usage

  first aid to help prevent infection in minor: Uses

-uses     -scrapes   -burns

Dosage and Administration

Directions

Adults and children 2 years of age and older:

Children under 2 years of age: ask a doctor before use.

  • clean the affected area
  • apply a small amount of this product to affected area 1 to 3 times daily
  • May be covered with a sterile bandage.
Description

Active ingredients (in each gram) Bacitracin 400 units Neomycin 3.5 mg Polymyxin B 5,000 units

Section 44425-7

  store at room temperature 68 - 77 F Other information

(20-25 C).

Section 50565-1

. If swallowed, get medical help or Keep out of reach of children

contact a Poison Control Center right away.

Section 51727-6

  mineral oil, petrolatum Inactive ingredients

Section 51945-4

Section 53413-1

  1-800-639-3803  Weekdays 9 AM to 4 PM EST Questions?

Section 55105-1

Purpose

First aid antibiotic

First aid antibiotic

First aid antibiotic

Section 55106-9

Active ingredients (in each gram)

Bacitracin 400 units

Neomycin 3.5 mg

Polymyxin B 5,000 units

Structured Label Content

Indications and Usage (34067-9)

  first aid to help prevent infection in minor: Uses

-uses     -scrapes   -burns

Dosage and Administration (34068-7)

Directions

Adults and children 2 years of age and older:

Children under 2 years of age: ask a doctor before use.

  • clean the affected area
  • apply a small amount of this product to affected area 1 to 3 times daily
  • May be covered with a sterile bandage.
Warnings and Precautions (34071-1)

Warnings

. For external use only

Do not use

Ask a doctor before use if you have

Stop use and ask a doctor if

  • if you are allergic to any of the ingredients in this product
  • in contact with the eyes or mucous membranes
  • over large areas of the body
  • deep or puncture wounds
  • animal bites
  • serious burns
  • symptoms persist for mroe than 7 days, the condition persists or gets worse
  • symptoms clear up and then occur again within a few days
  • a rash or other allergic reaction occurs
Section 44425-7 (44425-7)

  store at room temperature 68 - 77 F Other information

(20-25 C).

Section 50565-1 (50565-1)

. If swallowed, get medical help or Keep out of reach of children

contact a Poison Control Center right away.

Section 51727-6 (51727-6)

  mineral oil, petrolatum Inactive ingredients

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

  1-800-639-3803  Weekdays 9 AM to 4 PM EST Questions?

Section 55105-1 (55105-1)

Purpose

First aid antibiotic

First aid antibiotic

First aid antibiotic

Section 55106-9 (55106-9)

Active ingredients (in each gram)

Bacitracin 400 units

Neomycin 3.5 mg

Polymyxin B 5,000 units

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:06.401478 · Updated: 2026-03-14T23:01:33.532889