Label: BACITRACIN - bacitracin ointment
- NDC Code(s): 54868-3269-1
- Packager: Physicians Total Care, Inc.
- This is a repackaged label.
- Source NDC Code(s): 0295-1223
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Updated October 9, 2012
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- ACTIVE INGREDIENT
Bacitracin 500 units per gram.Close
First aid antibiotic.Close
First aid to help prevent infection in minor cuts, scrapes, and burns.Close
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.Close
- 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.Close
- KEEP OUT OF REACH OF CHILDREN.
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.Close
- Inactive ingredients
Mineral oil, white petrolatumClose
Store in controlled room temperature 59°-88°F (15°-30°C).Close
- PRINCIPAL DISPLAY PANEL
BACITRACIN OINTMENT U.S.P.
First Aid Antibiotic
NET WT. 1 OZ. (28.35g)
PAWTUCKET, RI 02862
Additional barcode labeling by:Close
Physicians Total Care, Inc.
Tulsa, Oklahoma 74146
- INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54868-3269(NDC:0295-1223) Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BACITRACIN (UNII: 58H6RWO52I) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN 500 [USP'U] in 1 g Inactive Ingredients Ingredient Name Strength MINERAL OIL (UNII: T5L8T28FGP) PETROLATUM (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54868-3269-1 1 in 1 CARTON 1 28.35 g in 1 TUBE 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 Business Operations Physicians Total Care, Inc. 194123980 relabel(54868-3269)