Your browser does not support JavaScript! BACITRACIN OINTMENT [PHYSICIANS TOTAL CARE, INC.]
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RxNorm Names

BACITRACIN ointment
[Physicians Total Care, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

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 54868-3269-1

package label

BACITRACIN OINTMENT U.S.P.

First Aid Antibiotic

NET WT. 1 OZ. (28.35g)



DENISON PHARMACEUTICALS
PAWTUCKET, RI   02862



Additional barcode labeling by:
Physicians Total Care, Inc.
Tulsa, Oklahoma      74146

BACITRACIN 
bacitracin ointment
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:54868-3269(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 DescriptionMarketing Start DateMarketing End Date
1NDC:54868-3269-11 in 1 CARTON
128.35 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333B08/22/1979
Labeler - Physicians Total Care, Inc. (194123980)
Establishment
NameAddressID/FEIBusiness Operations
Physicians Total Care, Inc.194123980relabel(54868-3269)

Revised: 10/2012
 
Physicians Total Care, Inc.

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