BACITRACIN ZINC

Main information

  • Trade name:
  • BACITRACIN ZINC- bacitracin zinc ointment
  • Composition:
  • BACITRACIN 500 [USP'U] in 1 g
  • Administration route:
  • TOPICAL
  • Prescription type:
  • OTC DRUG
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BACITRACIN ZINC- bacitracin zinc ointment
    United States
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • First aid antibiotic First aid to help prevent infection in - minor cuts - scrapes - burns

Status

  • Source:
  • DailyMed - NLM - National Library of Medicine
  • Authorization status:
  • OTC monograph final
  • Authorization number:
  • 58980-011-10
  • Last update:
  • 31-05-2019

Summary of Product characteristics: dosage, interactions, side effects

BACITRACIN ZINC- bacitracin zinc ointment

STRATUS PHARMACEUTICALS INC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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BACITRACIN ZINC

Drug Facts

Active ingredient (in each gram)

Bacitracin Zinc, USP 500 units

Purpos e

First aid antibiotic

Us es

First aid to help prevent infection in

minor cuts

scrapes

burns

Warnings

For external use only

Allergy alert

do not use if allergic to any of the ingredients

Do not use

in the eyes

over large areas of the body

Ask a doctor before use if you have

deep or puncture wounds

animal bites

serious burns

When using this product

do not use longer then one week unless directed by doctor

Stop use and ask a doctor if

condition persists or gets worse

a rash or other allergic reaction develop

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

away.

Directions

Clean 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

May be covered with a sterile bandage

Other information

Store at room temperature 59°F - 77°F (15°C - 25°C)

Before using any medication, read all label directions. Keep carton, it contains important

information.

Do not use if seal is punctured or is not visible

See crimp of tube and outside of carton for Lot Number and Expiration Date.

To open, reverse cap and puncture.

Inactive Ingredient

White petrolatum

Questions or comments?

Call toll-free 1-800-442-7882

Distributed by: Stratus Pharmaceuticals Inc.

12379 SW 130th Street

Miami, Florida 33186

PRINCIPAL DISPLAY PANEL - 28.35 g Tube Box

STRATUSCARE

NDC 58980-011-10

Bacitracin Zinc Ointment USP

First Aid Antibiotic

Net Wt. 1.0 OZ (28.35 g)

Distributed by:

STRATUS

PHARMACEUTICALS INC

BACITRACIN ZINC

bacitracin zinc ointment

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:58 9 8 0 -0 11

Route of Administration

TOPICAL

STRATUS PHARMACEUTICALS INC

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

BACITRACIN ZINC (UNII: 8 9 Y4M234ES) (BACITRACIN - UNII:58 H6 RWO52I)

BACITRACIN

50 0 [USP'U] in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

PETRO LATUM (UNII: 4T6 H12BN9 U)

Product Characteristics

Color

WHITE (OFF WHITE)

S core

S hap e

S iz e

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:58 9 8 0 -0 11-10

1 in 1 BOX

0 9 /15/20 17

1

28 .35 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH FINAL

pa rt333B

0 9 /15/20 17

Labeler -

ST RAT US PHARMACEUT ICALS INC (789001641)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

TARMAC PRODUCTS INC

0 59 8 9 0 49 1

MANUFACTURE(58 9 8 0 -0 11) , LABEL(58 9 8 0 -0 11) , PACK(58 9 8 0 -0 11)

Revised: 10/2017