61010-4401-1, Triple Antibiotic With Pain Relief

61010-4401-1, Triple Antibiotic With Pain Relief
SPL v2
SPL
SPL Set ID ca1df4a0-844d-4b1d-b972-f2704a8ebbab
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]) Neomycin (5 mg) Polymyxin B (5000 [iU]) Pramoxine (10 mg)
Inactive Ingredients
Petrolatum

Identifiers & Packaging

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

Drug Facts

Purpose

First Aid Antibiotic First Aid Antibiotic First Aid Antibiotic Pain Reliever

Medication Information

Purpose

First Aid Antibiotic

First Aid Antibiotic

First Aid Antibiotic

Pain Reliever

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 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
  • If you are allergic to any of the ingredients
  • Over large areas of the body
  • Longer than 1 week unless directed by a doctor
Other Information

Store at room temperature

Inactive Ingredients

White Petrolatum

Stop Use and Ask A Doctor If
  • The condition persists or gets worse
  • A rash or other allergic reaction develops
Active Ingredients (in Each Gram)

Bacitracin Zinc (500 units)

Neomycin Sulfate 5mg (3.5mg Neomycin)

Polymyxin B Sulfate (5000 units)

Pramoxine Hydrochloride (10mg)

Principal Display Panel 1 Oz. Tube Label

Safetec ®

Triple Antibiotic Ointment

with Pain Relief

Net Wt. 1 oz. (28.4g)

Reorder No. 53206

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 50569-3 (50569-3)

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

Purpose

First Aid Antibiotic

First Aid Antibiotic

First Aid Antibiotic

Pain Reliever

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
  • If you are allergic to any of the ingredients
  • Over large areas of the body
  • Longer than 1 week unless directed by a doctor
Other Information

Store at room temperature

Inactive Ingredients

White Petrolatum

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

Bacitracin Zinc (500 units)

Neomycin Sulfate 5mg (3.5mg Neomycin)

Polymyxin B Sulfate (5000 units)

Pramoxine Hydrochloride (10mg)

Principal Display Panel 1 Oz. Tube Label (Principal Display Panel - 1 oz. Tube Label)

Safetec ®

Triple Antibiotic Ointment

with Pain Relief

Net Wt. 1 oz. (28.4g)

Reorder No. 53206

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: 2026-02-15T12:02:47.692403 · Updated: 2026-03-14T23:02:32.213463