69103-5603. Triple Antibiotic

69103-5603. Triple Antibiotic
SPL v5
SPL
SPL Set ID bbf4b99c-9738-4855-82a6-f4e213924ec9
Route
TOPICAL
Published
Effective Date 2013-11-11
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 2022-07-25

Description

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

Purpose

First aid antibiotic


Medication Information

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)

Uses

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

Warnings

For external use only

Directions
  • clean affected area
  • apply a small amount 1 to 3 times daily
  • may cover with a sterile bandage
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 – 0.5g Pouch Label

Triple Antibiotic

Ointment

The Provision

First Aid

Line™

0.5 g

(1/57 oz.)


Structured Label Content

Uses

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

Purpose

First aid antibiotic

Warnings

For external use only

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 – 0.5g Pouch Label

Triple Antibiotic

Ointment

The Provision

First Aid

Line™

0.5 g

(1/57 oz.)


Advanced Ingredient Data


Raw Label Data

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