71927-016 American Safety & First Aid Triple Antibiotic

71927-016 American Safety & First Aid Triple Antibiotic
SPL v2
SPL
SPL Set ID eb0df2da-1688-c477-e053-2995a90a74a2
Route
TOPICAL
Published
Effective Date 2022-10-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bacitracin (400 [USP'U]) Neomycin (0.0035 g) Polymyxin B (5000 [USP'U])
Inactive Ingredients
Mineral Oil Petrolatum Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-10-17

Description

(in each gram) Bacitracin zinc 400 units Neoycin sulfate equivalent to 3.5 mg of neomycin base Polymyxin B sulfate 5,000 units

Purpose

First Aid antibiotic First Aid antibiotic First Aid antibiotic


Medication Information

Purpose

First Aid antibiotic

First Aid antibiotic

First Aid antibiotic

Description

(in each gram) Bacitracin zinc 400 units Neoycin sulfate equivalent to 3.5 mg of neomycin base Polymyxin B sulfate 5,000 units

Uses

first aid to help prevent infection in

  • minor cuts
  • scrapes
  • burns
Section 50566-9

Stop use and ask a doctor if

  • the condition persists or gets worse
  • a rash or other allergic reaction develops
Section 50570-1

Do not use

  • in eyes
  • over large areas of the body
  • if you are allergic to any of the ingredients
  • longer than 1 week unless directed by a doctor

Section 51945-4

Warning

For external use only.

Directions
  • clean affected area
  • apply small amount not more than 3 times daily
  • may be covered with a sterile bandage
Active Ingredients

(in each gram)

Bacitracin zinc 400 units

Neoycin sulfate equivalent to 3.5 mg of neomycin base

Polymyxin B sulfate 5,000 units

Inactive Ingredient

Mineral Oil, Petrolatum, Water

Keep Out of Reach of Children.

If swallowed contact a Poison Control Center right away.

Ask A Doctor Before Use If You Have

deep or puncture wounds, animal bites, or serious burns


Structured Label Content

Uses

first aid to help prevent infection in

  • minor cuts
  • scrapes
  • burns
Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • the condition persists or gets worse
  • a rash or other allergic reaction develops
Section 50570-1 (50570-1)

Do not use

  • in eyes
  • over large areas of the body
  • if you are allergic to any of the ingredients
  • longer than 1 week unless directed by a doctor

Section 51945-4 (51945-4)

Purpose

First Aid antibiotic

First Aid antibiotic

First Aid antibiotic

Warning

For external use only.

Directions
  • clean affected area
  • apply small amount not more than 3 times daily
  • may be covered with a sterile bandage
Active Ingredients (Active ingredients)

(in each gram)

Bacitracin zinc 400 units

Neoycin sulfate equivalent to 3.5 mg of neomycin base

Polymyxin B sulfate 5,000 units

Inactive Ingredient

Mineral Oil, Petrolatum, Water

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed contact a Poison Control Center right away.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

deep or puncture wounds, animal bites, or serious burns


Advanced Ingredient Data


Raw Label Data

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