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NDC 45802-0060-70 Bacitracin 500 [USP'U]/g Details

Bacitracin 500 [USP'U]/g

Bacitracin is a TOPICAL OINTMENT in the HUMAN OTC DRUG category. It is labeled and distributed by Padagis Israel Pharmaceuticals Ltd. The primary component is BACITRACIN.

MedlinePlus Drug Summary

Bacitracin is used to help prevent minor skin injuries such as cuts, scrapes, and burns from becoming infected. Bacitracin is in a class of medications called antibiotics. Bacitracin works by stopping the growth of bacteria.

Related Packages: 45802-0060-70
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Bacitracin Topical

Product Information

NDC	45802-0060
Product ID	45802-060_bba42abe-613c-4d5b-9eee-bb73e8ca6674
Associated GPIs	90100010004210
GCN Sequence Number	030027
GCN Sequence Number Description	bacitracin PACKET 500 UNIT/G TOPICAL
HIC3	Q5W
HIC3 Description	TOPICAL ANTIBIOTICS
GCN	31811
HICL Sequence Number	004047
HICL Sequence Number Description	BACITRACIN
Brand/Generic	Generic
Proprietary Name	Bacitracin
Proprietary Name Suffix	n/a
Non-Proprietary Name	Bacitracin
Product Type	HUMAN OTC DRUG
Dosage Form	OINTMENT
Route	TOPICAL
Active Ingredient Strength	500
Active Ingredient Units	[USP'U]/g
Substance Name	BACITRACIN
Labeler Name	Padagis Israel Pharmaceuticals Ltd
Pharmaceutical Class	Decreased Cell Wall Synthesis & Repair [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part333B
Listing Certified Through	2024-12-31

Package

Package Images

NDC 45802-0060-70 (45802006070)

Pricing Information	N/A
NDC Package Code	45802-060-70
Billing NDC	45802006070
Package	144 PACKET in 1 CARTON (45802-060-70) / .9 g in 1 PACKET
Marketing Start Date	2011-06-20
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL bebbedf6-dd65-47a4-aa3e-ad197b3e05a1 Details

Active ingredient (each gram contains)

Bacitracin 500 units

Purpose

First aid antibiotic

Uses

first aid to help prevent infection in:

•: minor cuts
•: scrapes
•: burns

Warnings

For external use only

Do not use

•: in the eyes
•: over large areas of the body
•: if you are allergic to any of the ingredients

Ask a doctor before use if you have

•: deep or puncture wounds
•: animal bites
•: serious burns

Stop use and ask a doctor if

•: you need to use longer than 1 week
•: condition persists or gets worse
•: rash or other allergic reaction develops

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

•: clean the affected area
•: apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily
•: may be covered with a sterile bandage

Other information

•: store at 20°-25°C (68°-77°F)

Inactive ingredients

light mineral oil, white petrolatum

Questions or comments?

1-800-719-9260

Principal Display Panel

Bacitracin

First Aid Antibiotic Ointment

144 Unit Dose

NET WT 0.9 g Each

INGREDIENTS AND APPEARANCE

BACITRACIN

bacitracin ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:45802-060
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BACITRACIN (UNII: 58H6RWO52I) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN	500 [USP'U] in 1 g

Ingredient Name	Strength
Inactive Ingredients
LIGHT MINERAL OIL (UNII: N6K5787QVP)
PETROLATUM (UNII: 4T6H12BN9U)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:45802-060-70	144 in 1 CARTON	06/20/2011
1		0.9 g in 1 PACKET; Type 0: Not a Combination Product
2	NDC:45802-060-01	1 in 1 CARTON	09/01/2011
2		14 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC:45802-060-03	1 in 1 CARTON	08/05/2011
3		28 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333B	06/20/2011

Labeler - Padagis Israel Pharmaceuticals Ltd (600093611)

Revised: 11/2021

Document Id: bba42abe-613c-4d5b-9eee-bb73e8ca6674

Set id: bebbedf6-dd65-47a4-aa3e-ad197b3e05a1

Version: 6

Effective Time: 20211110