1161 Bacitracin Ndc 67777-116-10

1161 Bacitracin Ndc 67777-116-10
SPL v10
SPL
SPL Set ID 7f8752c7-6839-261d-e053-2991aa0a0c30
Route
TOPICAL
Published
Effective Date 2016-09-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bacitracin (500 [USP'U])
Inactive Ingredients
White Petrolatum Paraffin Mineral Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-09-12
Description

Bacitracin (500 units in each gram)

Purpose

First Aid Antibiotic

Medication Information

Purpose

First Aid Antibiotic

Description

Bacitracin (500 units in each gram)

Use

First aid to help prevent infection in minor cuts, scrapes, and burns

Label

1161 Bacitracin Ointment

Section 50565-1

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

Warnings

For External Use Only

Directions

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.

Do Not Use
  • In the eyes or apply over large areas of the body
  • If you are allergic to any of the ingredients
  • Longer than 1 week unless directed by a doctor
Active Ingredient

Bacitracin (500 units in each gram)

Other Information

Store at room temperature

Inactive Ingredients

Hard Paraffin, Liquid Paraffin, White Soft Paraffin

Ask A Doctor Before Use If You Have

deep or puncture wounds, animal bites, or serious burns

Structured Label Content

Use

First aid to help prevent infection in minor cuts, scrapes, and burns

Label

1161 Bacitracin Ointment

Section 50565-1 (50565-1)

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

Purpose

First Aid Antibiotic

Warnings

For External Use Only

Directions

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.

Do Not Use (Do not use)
  • In the eyes or apply over large areas of the body
  • If you are allergic to any of the ingredients
  • Longer than 1 week unless directed by a doctor
Active Ingredient

Bacitracin (500 units in each gram)

Other Information (Other information)

Store at room temperature

Inactive Ingredients (Inactive ingredients)

Hard Paraffin, Liquid Paraffin, White Soft Paraffin

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

deep or puncture wounds, animal bites, or serious burns

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:29.277347 · Updated: 2026-03-14T23:05:15.511736