61010-4400-2, triple antibiotic

61010-4400-2, triple antibiotic
SPL v2
SPL
SPL Set ID 59494d5c-dd8a-431c-8e6a-4e1151ba7460
Route
topical
Published
Effective Date 2022-07-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
bacitracin (400 [iU]) neomycin (5 mg) polymyxin b (5000 [iU])
Inactive Ingredients
petrolatum

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2022-07-25
Purpose

First aid antibiotic

Description

(in each gram) Bacitracin Zinc (400 units Bacitracin) Neomycin sulfate (3.5 mg Neomycin) Polymyxin B Sulfate (Polymyxin B 5000 units)

Medication Information

Warnings

For external use only

Uses

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

Purpose

First aid antibiotic

Directions
  • clean affected area
  • apply a small amount 1 to 3 times daily
  • may cover with a sterile bandage
Description

(in each gram) Bacitracin Zinc (400 units Bacitracin) Neomycin sulfate (3.5 mg Neomycin) Polymyxin B Sulfate (Polymyxin B 5000 units)

Do Not Use
  • internally
  • in eyes
  • over large areas of the body or on puncture wounds, animal bites or serious burns
  • for more than 1 week unless directed by a doctor
  • if you are allergic to any of the ingredients
Active Ingredients

(in each gram)

Bacitracin Zinc (400 units Bacitracin)

Neomycin sulfate (3.5 mg Neomycin)

Polymyxin B Sulfate (Polymyxin B 5000 units)

Inactive Ingredient

petrolatum

Stop Use and Ask A Doctor If
  • a rash or allergic reaction develops
  • condition worsens or persists
Keep Out of Reach of Children

If ingested, contact a Poison Control Center right away.

Principal Display Panel – 28 G Tube Label

Safetec ®

Triple

Antibiotic

Ointment

First Aid

Infection Protection

To Help Prevent Infection

in Minor Cuts, Scrapes,

and Burns

Net Wt. 1 oz. (28.4g)

Structured Label Content

Warnings

For external use only

Uses

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

Purpose

First aid antibiotic

Directions
  • clean affected area
  • apply a small amount 1 to 3 times daily
  • may cover with a sterile bandage
Do Not Use (Do not use)
  • internally
  • in eyes
  • over large areas of the body or on puncture wounds, animal bites or serious burns
  • for more than 1 week unless directed by a doctor
  • if you are allergic to any of the ingredients
Active Ingredients (Active ingredients)

(in each gram)

Bacitracin Zinc (400 units Bacitracin)

Neomycin sulfate (3.5 mg Neomycin)

Polymyxin B Sulfate (Polymyxin B 5000 units)

Inactive Ingredient (Inactive ingredient)

petrolatum

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • a rash or allergic reaction develops
  • condition worsens or persists
Keep Out of Reach of Children (Keep out of reach of children)

If ingested, contact a Poison Control Center right away.

Principal Display Panel – 28 G Tube Label (Principal Display Panel – 28 g Tube Label)

Safetec ®

Triple

Antibiotic

Ointment

First Aid

Infection Protection

To Help Prevent Infection

in Minor Cuts, Scrapes,

and Burns

Net Wt. 1 oz. (28.4g)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:47.040734 · Updated: 2026-03-14T23:02:30.868416