61010-4404 Triple Antibiotic With Pain Relief

61010-4404 Triple Antibiotic With Pain Relief
SPL v2
SPL
SPL Set ID 9993c204-6e61-4da3-90ef-2b7dfa09c920
Route
TOPICAL
Published
Effective Date 2019-11-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-11-01
Description

Drug Facts

Purpose

First Aid Antibiotic

Medication Information

Purpose

First Aid Antibiotic

Description

Drug Facts

Uses

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

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away

Section 50566-9

Stop use and ask a doctor ifthe condition persists or gets worse, or if a rash or other allergic reaction develops

Section 50569-3

Ask a doctor before use if you havedeep or puncture wounds, animal bites, or serious burns

Warnings

For external use only

Directions

Clean the affected area. Apply a small amount (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 Zinc (500 units in each gram)

Other Information

Store at room temperature

Inactive Ingredients

Hard Paraffin, Liquid Paraffin, White Soft Paraffin

Principal Display Panel – Tube Label

Safetec ®

Single Antibiotic Ointment

First Aid Infection Protection with Bacitracin Zinc

Net Wt. 1 oz. (28.4g)

Reorder No. 53301

Manufactured for: Safetec of America, Inc.

Buffalo, NY 14215 | 1-800-456-7077

Made in IndiaKD/503

Structured Label Content

Uses

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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away

Section 50566-9 (50566-9)

Stop use and ask a doctor ifthe condition persists or gets worse, or if a rash or other allergic reaction develops

Section 50569-3 (50569-3)

Ask a doctor before use if you havedeep or puncture wounds, animal bites, or serious burns

Purpose

First Aid Antibiotic

Warnings

For external use only

Directions

Clean the affected area. Apply a small amount (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 Zinc (500 units in each gram)

Other Information

Store at room temperature

Inactive Ingredients

Hard Paraffin, Liquid Paraffin, White Soft Paraffin

Principal Display Panel – Tube Label

Safetec ®

Single Antibiotic Ointment

First Aid Infection Protection with Bacitracin Zinc

Net Wt. 1 oz. (28.4g)

Reorder No. 53301

Manufactured for: Safetec of America, Inc.

Buffalo, NY 14215 | 1-800-456-7077

Made in IndiaKD/503

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:47.600106 · Updated: 2026-03-14T23:02:30.868416