Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 64e1f3b7-cc15-24a3-e053-2a91aa0a4521
Route
TOPICAL
Published
Effective Date 2013-05-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2013-05-30
Description

Bacitracin Zinc (equal to 500 bacitracin units)

Purpose

First Aid Antibiotic

Medication Information

Purpose

First Aid Antibiotic

Description

Bacitracin Zinc (equal to 500 bacitracin units)

Uses

■ first aid to help prevent infection in minor ■ cuts ■ scrapes ■ burns

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

■ Not for opthalmic use Do not use ■ in the eyes ■ if you are allergic to any of the ingredients ■ over large areas of the body longer than 1 week unless directed by a doctor

Package Label

Other Information

■ store at room temperature 15-30C (59-86F)

■ avoid excessive heat and humidity

Inactive Ingredients

hard paraffin, liquid paraffin, white soft paraffin, lanolin

Stop Use and Ask A Doctor If

■ the condition persists or gets worse

■ 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.

Active Ingredient (in Each Gram)

Bacitracin Zinc (equal to 500 bacitracin units)

Ask A Doctor Before Use in Case Of

■ deep or puncture wounds

■ animal bites ■ serious burns

Structured Label Content

Uses

■ first aid to help prevent infection in minor ■ cuts ■ scrapes ■ burns

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)

■ Not for opthalmic use Do not use ■ in the eyes ■ if you are allergic to any of the ingredients ■ over large areas of the body longer than 1 week unless directed by a doctor

Package Label

Other Information

■ store at room temperature 15-30C (59-86F)

■ avoid excessive heat and humidity

Inactive Ingredients

hard paraffin, liquid paraffin, white soft paraffin, lanolin

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

■ the condition persists or gets worse

■ a rash or other allergic reaction develops

Keep Out of Reach of Children (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.

Active Ingredient (in Each Gram) (Active Ingredient (in each gram))

Bacitracin Zinc (equal to 500 bacitracin units)

Ask A Doctor Before Use in Case Of (Ask a doctor before use in case of)

■ deep or puncture wounds

■ animal bites ■ serious burns

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:30.904649 · Updated: 2026-03-14T22:55:01.972489