Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate Ointment

Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate Ointment
SPL v1
SPL
SPL Set ID 149065ec-0c18-43e7-89de-6540bf48207b
Route
TOPICAL
Published
Effective Date 2011-07-21
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 FINAL Active Since 2012-04-25

Description

(in each gram) Bacitracin zinc, USP 400 units Neomycin sulfate, USP 3.5 mg Polymyxin B sulfate, USP 5,000 units

Purpose

First aid antibiotic

How Supplied

Triple Antibiotic Ointment comes in 28gr tubes NDC - 68788-9811-2


Medication Information

Purpose

First aid antibiotic

How Supplied

Triple Antibiotic Ointment comes in 28gr tubes

NDC - 68788-9811-2

Description

(in each gram) Bacitracin zinc, USP 400 units Neomycin sulfate, USP 3.5 mg Polymyxin B sulfate, USP 5,000 units

Uses

Helps prevent infection in

  • minor cuts
  • scrapes
  • burns
Warnings

For external  use only

Allergy alert:

  • do not use if allergic to any of the ingredients
Directions
  • clean affected area
  • apply a small 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
Do Not Use
  • in the eyes
  • over large areas of the body
Questions?

1-800-432-8534 between 9 am and 4 pm EST, Monday – Friday.



Relabeled By Preferred Pharmaceuticals, Inc

Other Information
  • Store at controlled room temperature 59º - 86ºF (15º - 30ºC).
  • Protect from freezing.
Active Ingredients

(in each gram)

Bacitracin zinc, USP 400 units

Neomycin sulfate, USP 3.5 mg

Polymyxin B sulfate, USP 5,000 units

Inactive Ingredient

White petrolatum

When Using This Product
  • do not use longer than 1 week unless directed by a doctor
Stop Use and Ask A Doctor If
  • condition persists or gets worse
  • a rash or other allergic reaction develops
Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Ask A Doctor Before Use If You Have
  • deep or puncture wounds
  • animal bites
  • serious burns
Package Label.principal Display Panel

Structured Label Content

Uses (USES)

Helps prevent infection in

  • minor cuts
  • scrapes
  • burns
Purpose (PURPOSE)

First aid antibiotic

Warnings (WARNINGS)

For external  use only

Allergy alert:

  • do not use if allergic to any of the ingredients
Directions (DIRECTIONS)
  • clean affected area
  • apply a small 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
Do Not Use (DO NOT USE)
  • in the eyes
  • over large areas of the body
Questions? (QUESTIONS?)

1-800-432-8534 between 9 am and 4 pm EST, Monday – Friday.



Relabeled By Preferred Pharmaceuticals, Inc

How Supplied (HOW SUPPLIED)

Triple Antibiotic Ointment comes in 28gr tubes

NDC - 68788-9811-2

Other Information
  • Store at controlled room temperature 59º - 86ºF (15º - 30ºC).
  • Protect from freezing.
Active Ingredients (ACTIVE INGREDIENTS)

(in each gram)

Bacitracin zinc, USP 400 units

Neomycin sulfate, USP 3.5 mg

Polymyxin B sulfate, USP 5,000 units

Inactive Ingredient (INACTIVE INGREDIENT)

White petrolatum

When Using This Product (WHEN USING THIS PRODUCT)
  • do not use longer than 1 week unless directed by a doctor
Stop Use and Ask A Doctor If (STOP USE AND ASK A DOCTOR IF)
  • condition persists or gets worse
  • a rash or other allergic reaction develops
Keep Out of Reach of Children. (KEEP OUT OF REACH OF CHILDREN.)

If swallowed, get medical help or 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
  • serious burns
Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

Advanced Ingredient Data


Raw Label Data

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