BACITRACIN

Main information

  • Trade name:
  • BACITRACIN ointment
  • Composition:
  • BACITRACIN 500 [USP'U] in 1 g
  • Prescription type:
  • OTC DRUG
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BACITRACIN ointment
    United States
  • Language:
  • English

Status

  • Source:
  • DailyMed - NLM - National Library of Medicine
  • Authorization status:
  • OTC monograph final
  • Last update:
  • 06-11-2017

Summary of Product characteristics: dosage, interactions, side effects

BACITRACIN- bacitracin ointment

Denison 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

ACTIVE INGREDIENT

Bacitracin 500 units per gram.

PURPOSE

First aid antibiotic.

INDICATIONS

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

WARNINGS

For external use only. Do not use in the eyes or apply over large areas of the body. In case of deep

puncture wounds, animal bites, or serious burns, consult a doctor.

Stop use and consult a doctor

if the condition persists or gets worse, or if a rash or other allergic reaction develops. Do not use if

you are allergic to any of the ingredients. Do not use longer than one week unless directed by a doctor.

KEEP OUT OF REACH OF CHILDREN.

DIRECTIONS

After gentle washing, apply a small amount (an amount equal to the surface area of the tip of a finger)

directly to the affected areas and cover with sterile gauze if desired. May be applied 1 to 3 times daily

as the condition indicates.

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center

immediately.

Inactive ingredients

ALSO CONTAINS

Mineral oil, white petrolatum

Storage

Store in controlled room temperature 59°-88°F (15°-30°C).

PRINCIPAL DISPLAY PANEL

NDC 0295-1223-95

BACITRACIN OINTMENT U.S.P.

First Aid Antibiotic

NET WT. 1 OZ. (28.35g)

BACITRACIN

bacitracin ointment

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 29 5-1223

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

BACITRACIN (UNII: 58 H6 RWO52I) (BACITRACIN - UNII:58 H6 RWO52I)

BACITRACIN

50 0 [USP'U] in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

MINERAL O IL (UNII: T5L8 T28 FGP)

PETRO LATUM (UNII: 4T6 H12BN9 U)

Denison Pharmaceuticals, Inc.

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 29 5-1223-9 5

1 in 1 CARTON

1

28 .35 g in 1 TUBE

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH FINAL

pa rt331

0 8 /22/19 79

Labeler -

Denison Pharmaceuticals, Inc. (001207208)

Revised: 12/2009