61010-5603,triple Antibiotic Ointment™

61010-5603,triple Antibiotic Ointment™
SPL v5
SPL
SPL Set ID 2c2aa8af-2adb-4f59-ac20-15818d0e28e7
Route
TOPICAL
Published
Effective Date 2010-09-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bacitracin (400 [iU]) Neomycin (3.5 mg) Polymyxin B (5000 [iU])
Inactive Ingredients
Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2007-03-30
Description

Drug Facts

Purpose

First Aid Antibiotic First Aid Antibiotic First Aid Antibiotic

Medication Information

Purpose

First Aid Antibiotic First Aid Antibiotic First Aid Antibiotic

Description

Drug Facts

Uses

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

Section 42229-5

Drug Facts

Purposes

First Aid Antibiotic

First Aid Antibiotic

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:
  • in the eyes
  • internally
  • over large areas of the body
  • if you are allergic to any of the ingredients
  • longer than 1 week unless directed by a doctor
Other Information
  • Store at room temperature (do not freeze)
  • Do Not Use any Opened or Torn Packets
Inactive Ingredient

Petrolatum

Ask A Doctor Before Use:
  • in case of deep or puncture wounds, animal bites, or serious burns
Stop Use and Ask A Doctor If:
  • the condition persists or gets worse
  • a rash or other allergic reaction develops
Active Ingredient (in Each Gram)

Bacitracin Zinc (400 units Bacitracin)

Neomycin Sulfate 5 mg (equivalent to 3.5 mg of Neomycin base)

Polymyxin-B Sulfate 5000 units

Principal Display Panel – Box Label

NDC 61010-5603-4

Safetec

First Aid

Triple Antibiotic Ointment™

First Aid to Help Prevent

Infection In Minor Cuts,

Scrapes, and Burns

Reorder no. 53214

To reorder:

Call: 1-800-456-7077

Fax: 716-895-2969

Online: www.safetec.com

Questions Or Comments? 1 800 456 7077

Manufactured by

SAFETEC OF AMERICA, Inc.

Buffalo, NY 14215 • 800-456-7077

www.safetec.com

Principal Display Panel – 0.5g Pouch Label

Safetec

Triple Antibiotic Ointment™

0.5 g (1/57 oz.)

Safetec of America, Inc.

Buffalo, NY 14215

800-456-7077

Keep This and All Drugs Out of the Reach of Children.

In case of accidental ingestion, seek professional assistance or contact a poison control center immediately.

Structured Label Content

Uses

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

Section 42229-5 (42229-5)

Drug Facts

Purposes

First Aid Antibiotic

First Aid Antibiotic

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
  • internally
  • over large areas of the body
  • if you are allergic to any of the ingredients
  • longer than 1 week unless directed by a doctor
Other Information
  • Store at room temperature (do not freeze)
  • Do Not Use any Opened or Torn Packets
Inactive Ingredient

Petrolatum

Ask A Doctor Before Use: (Ask a doctor before use:)
  • in case of deep or puncture wounds, animal bites, or serious burns
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 Ingredient (in Each Gram) (Active Ingredient (in each gram))

Bacitracin Zinc (400 units Bacitracin)

Neomycin Sulfate 5 mg (equivalent to 3.5 mg of Neomycin base)

Polymyxin-B Sulfate 5000 units

Principal Display Panel – Box Label (PRINCIPAL DISPLAY PANEL – Box Label)

NDC 61010-5603-4

Safetec

First Aid

Triple Antibiotic Ointment™

First Aid to Help Prevent

Infection In Minor Cuts,

Scrapes, and Burns

Reorder no. 53214

To reorder:

Call: 1-800-456-7077

Fax: 716-895-2969

Online: www.safetec.com

Questions Or Comments? 1 800 456 7077 (Questions or Comments? 1-800-456-7077)

Manufactured by

SAFETEC OF AMERICA, Inc.

Buffalo, NY 14215 • 800-456-7077

www.safetec.com

Principal Display Panel – 0.5g Pouch Label (PRINCIPAL DISPLAY PANEL – 0.5g Pouch Label)

Safetec

Triple Antibiotic Ointment™

0.5 g (1/57 oz.)

Safetec of America, Inc.

Buffalo, NY 14215

800-456-7077

Keep This and All Drugs Out of the Reach of Children. (Keep this and all drugs out of the reach of children.)

In case of accidental ingestion, seek professional assistance or contact a poison control center immediately.

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:47.031295 · Updated: 2026-03-14T23:02:30.868416