81417-003 my medic triple antibiotic

81417-003 my medic triple antibiotic
SPL v2
SPL
SPL Set ID e7398df8-8e23-5439-e053-2a95a90ac3aa
Route
topical
Published
Effective Date 2022-08-29
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 2022-08-29

Purpose

first aid antibiotic

Description

(in each gram) Bacitracin Zinc (bacitracin 400 units) Neoycin sulfate (neoycin 3.5 mg) Polymyxin B sulfate (polymyxin B 5,000 units)


Medication Information

Uses

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

Purpose

first aid antibiotic

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

Inactive Ingredients

Mineral oil, Petrolatum, Purified water

Description

(in each gram) Bacitracin Zinc (bacitracin 400 units) Neoycin sulfate (neoycin 3.5 mg) Polymyxin B sulfate (polymyxin B 5,000 units)

Section 44425-7

Store at room temperature

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if

  • the condition persists or gets worse
  • a rash or other allergic reaction develops
Section 50569-3

Ask a doctor before use if you have

  • deep or puncture wounds
  • animal bites,
  • serious burns
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 Ingredient

(in each gram)

Bacitracin Zinc (bacitracin 400 units)

Neoycin sulfate (neoycin 3.5 mg)

Polymyxin B sulfate

(polymyxin B 5,000 units)


Structured Label Content

Uses

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

Purpose

first aid antibiotic

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

Inactive Ingredients (Inactive ingredients)

Mineral oil, Petrolatum, Purified water

Section 44425-7 (44425-7)

Store at room temperature

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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 50569-3 (50569-3)

Ask a doctor before use if you have

  • deep or puncture wounds
  • animal bites,
  • serious burns
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 Ingredient

(in each gram)

Bacitracin Zinc (bacitracin 400 units)

Neoycin sulfate (neoycin 3.5 mg)

Polymyxin B sulfate

(polymyxin B 5,000 units)


Advanced Ingredient Data


Raw Label Data

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