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Bacitracin by Denison Pharmaceuticals, Inc.

Medically reviewed on Dec 25, 2017

Dosage form: ointment
Ingredients: BACITRACIN 500[USP'U] in 1g
Labeler: Denison Pharmaceuticals, Inc.
NDC Code: 0295-1223

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.

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:0295-1223
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN (BACITRACIN) BACITRACIN500 [USP'U]  in 1 g
Inactive Ingredients
Ingredient NameStrength
MINERAL OIL 
PETROLATUM 
Packaging
#Item CodePackage Description
1NDC:0295-1223-951 TUBE (1 TUBE) in 1 CARTON
128.35 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33108/22/1979
Labeler - Denison Pharmaceuticals, Inc. (001207208)

 
Denison Pharmaceuticals, Inc.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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