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

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


Medication Information

Uses

first aid to help prevent infection in

  • minor cuts
  • scrapes
  • burns
Purpose

First Aid antibiotic

First Aid antibiotic

First Aid antibiotic

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

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

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.

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
Purpose

First Aid antibiotic

First Aid antibiotic

First Aid antibiotic

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

Warning

For external use only.

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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