1162_1163_bacitracin_ointment

1162_1163_bacitracin_ointment
SPL v5
SPL
SPL Set ID e1166948-5d80-44c2-a20d-78be631647d9
Route
TOPICAL
Published
Effective Date 2024-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bacitracin (500 [iU])
Inactive Ingredients
Mineral Oil Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2009-12-01
Description

Active ingredient               Purpose Bacitracin 500 Units                Antibiotic

Indications and Usage

Ask a doctor before use: • in case of deep or puncture wounds • animal bites • serious burns

Purpose

First aid to help prevent infection in: Minor cuts scrapes burns

Dosage and Administration

• clean the affected areas • apply a small amount of product (an amount equal to the surface area of the tip of the finger) on the area 1 to 3 times daily • may be covered with a sterile bandage

Medication Information

Indications and Usage

Ask a doctor before use:

  • •
    in case of deep or puncture wounds
  • •
    animal bites
  • •
    serious burns
Purpose

First aid to help prevent infection in:

Minor cuts

scrapes

burns

Dosage and Administration

• clean the affected areas • apply a small amount of product (an amount equal to the surface area of the tip of the finger) on the area 1 to 3 times daily • may be covered with a sterile bandage

Description

Active ingredient               Purpose Bacitracin 500 Units                Antibiotic

Section 55106-9

Active ingredient               Purpose

Bacitracin 500 Units                Antibiotic



Warnings:

For external use only

Do Not Use:
  • •
    if you are allergic to any of the ingredients

  • •
    in the eyes
  • •
    over large areas of the body
  • •
    longer than 1 week unless directed by a doctor

Other Information
  • •
    store at controlled room temperature 15°-30° C (59°-86° F)
Inactive Ingredients

Light Mineral Oil, White Petrolatum

Principal Display Panel

Relabeled By:

Proficient Rx LP

Thousand Oaks, CA 91320

Bacitracin Ointment:

bacitracin-galentic-ointment-01.jpg

Dosage and Administration:
  • •
    clean the affected areas
  • •
    apply a small amount of product (an amount equal to the surface area of the tip of the finger) on the area 1 to 3 times daily
  • •
    may be covered with a sterile bandage

Stop Use and Ask A Doctor If
  • •
     the condition persists or gets worse, or if a rash or other allergic reaction develops.
Keep Out of Reach of Children

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

Structured Label Content

Section 55106-9 (55106-9)

Active ingredient               Purpose

Bacitracin 500 Units                Antibiotic



Purpose

First aid to help prevent infection in:

Minor cuts

scrapes

burns

Warnings:

For external use only

Do Not Use: (Do not use:)
  • •
    if you are allergic to any of the ingredients

  • •
    in the eyes
  • •
    over large areas of the body
  • •
    longer than 1 week unless directed by a doctor

Other Information (Other information)
  • •
    store at controlled room temperature 15°-30° C (59°-86° F)
Inactive Ingredients (Inactive ingredients)

Light Mineral Oil, White Petrolatum

Indications and Usage

Ask a doctor before use:

  • •
    in case of deep or puncture wounds
  • •
    animal bites
  • •
    serious burns
Principal Display Panel

Relabeled By:

Proficient Rx LP

Thousand Oaks, CA 91320

Bacitracin Ointment:

bacitracin-galentic-ointment-01.jpg

Dosage and Administration:
  • •
    clean the affected areas
  • •
    apply a small amount of product (an amount equal to the surface area of the tip of the finger) on the area 1 to 3 times daily
  • •
    may be covered with a sterile bandage

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • •
     the condition persists or gets worse, or if a rash or other allergic reaction develops.
Keep Out of Reach of Children (Keep out of reach of children)

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:43.547721 · Updated: 2026-03-14T23:02:25.522673