Bacitracin: Package Insert and Label Information

BACITRACIN — bacitracin ointment
Physicians Total Care, 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.

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
(click image for full-size original)

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 Type HUMAN OTC DRUG Item Code (Source) NDC:54868-3269(NDC:0295-1223)
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BACITRACIN (BACITRACIN) BACITRACIN 500 [USP’U] in 1 g
Inactive Ingredients
Ingredient Name Strength
MINERAL OIL
PETROLATUM
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-3269-1 1 TUBE (1 TUBE) in 1 CARTON contains a TUBE
1 28.35 g in 1 TUBE This package is contained within the CARTON (54868-3269-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part333B 08/22/1979
Labeler — Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel (54868-3269)

Revised: 10/2012 Physicians Total Care, Inc.

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