Bacitracin Zinc and Polymyxin B Sulfate description, usages, side effects, indications, overdosage, supplying and lots more!

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Bacitracin Zinc and Polymyxin B Sulfate

H.J. Harkins Company, Inc.

Fougera Double Antibiotic Ointment(Bacitracin Zinc and Polymyxin B Sulfate Ointment USP)


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredients (in each gram)

Bacitracin Zinc (equal to 500 bacitracin units)

Polymyxin B Sulfate (equal to 10,000 polymyxin B units)

Purpose

Antibiotic

Antibiotic

Uses

Uses first aid to help prevent infection in

  • minor cuts
  • scrapes
  • burn

Warnings

For external use only

Do not use

  • in the eyes
  • over large areas of the body
  • if you are allergic to any of the ingredients

Ask a doctor before use in case of deep or puncture wounds, animal bites or serious bums

When using this product do not use longer than 1 week unless directed by a doctor

Stop use and ask a doctor if

  • the condition persists or gets worse
  • if 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.

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

Other information

  • do not use if seal is punctured or is not visible. To open, reverse cap to puncture seal • store at room temperature
  • see crimp of tube for Lot No. and Exp. date

Inactive ingredient white petrolatum

Questions or comments ? call toll free 1-800-645-9833

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 1/2 Oz CONTAINER

Fougera®

NDC 0168-0021-35

Double Antibiotic Ointment
(Bacitracin Zinc and Polymyxin B Sulfate Ointment USP)

Repacked by:
H.J. Harkins Company, Inc.
513 Sandydale Drive
Nipomo, CA 93444

Bacitracin Zinc and Polymyxin B Sulfate

Bacitracin Zinc and Polymyxin B Sulfate

Bacitracin Zinc and Polymyxin B Sulfate OINTMENT

Product Information

Product Type Human otc drug label Item Code (Source) NDC:52959-054(NDC:0168-0021)
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
BACITRACIN ZINC BACITRACIN 500 [USP'U]
Polymyxin B Sulfate POLYMYXIN B 1000 [USP'U]

Inactive Ingredients

Ingredient Name Strength
petrolatum

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:52959-054-03 14.17 in 1 TUBE
2 NDC:52959-054-07 28.34 in 1 TUBE
3 NDC:52959-054-44 144 in 1 TUBE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
partB part333B 2010-01-06


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Be sure to consult your doctor before taking any medication!
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