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NDC 70000-0093-01 Leader Poly Bacitracin 500; 10000 [USP'U]/g; [USP'U]/g Details

Leader Poly Bacitracin 500; 10000 [USP'U]/g; [USP'U]/g

Leader Poly Bacitracin is a TOPICAL OINTMENT in the HUMAN OTC DRUG category. It is labeled and distributed by Cardinal Health 110, Inc.. The primary component is BACITRACIN ZINC; POLYMYXIN B SULFATE.

Product Information

NDC	70000-0093
Product ID	70000-0093_f0916063-f6cb-4160-96fb-f2362dd726dd
Associated GPIs	90109802104200
GCN Sequence Number	018322
GCN Sequence Number Description	bacitracin zinc/polymyxin B OINT. (G) 500-10K/G TOPICAL
HIC3	Q5W
HIC3 Description	TOPICAL ANTIBIOTICS
GCN	62427
HICL Sequence Number	007495
HICL Sequence Number Description	BACITRACIN ZINC/POLYMYXIN B SULFATE
Brand/Generic	Generic
Proprietary Name	Leader Poly Bacitracin
Proprietary Name Suffix	n/a
Non-Proprietary Name	FIRST AID ANTIBIOTIC
Product Type	HUMAN OTC DRUG
Dosage Form	OINTMENT
Route	TOPICAL
Active Ingredient Strength	500; 10000
Active Ingredient Units	[USP'U]/g; [USP'U]/g
Substance Name	BACITRACIN ZINC; POLYMYXIN B SULFATE
Labeler Name	Cardinal Health 110, Inc.
Pharmaceutical Class	Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part333B
Listing Certified Through	2024-12-31

Package

Package Images

NDC 70000-0093-01 (70000009301)

Pricing Information
NDC Package Code	70000-0093-1
Billing NDC	70000009301
Package	1 TUBE in 1 CARTON (70000-0093-1) / 14 g in 1 TUBE
Marketing Start Date	2021-06-01
NDC Exclude Flag	N
Price Per Unit	0.145
Pricing Unit	GM
Effective Date	2023-05-17
NDC Description	POLY BACITRACIN OINTMENT
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	4, 5
Classification for Rate Setting	G
As of Date	2024-02-21

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL 442e11aa-7d14-44f9-bf14-446018f1de0d Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients (In each gram)

Bacitracin 500 units

Polymyxin B Sulfate 10,000 units

Purpose

First aid antibiotic

Uses

First aid to help prevent infection in minor:

cuts
scrapes
burns

Warnings

For external use only

Allergy alert:

do not use if you are allergic to any of the ingredients

Do not use

in or near the eyes
on large areas of the body

Consult a doctor before use if you have

deep or puncture wounds
animal bites
serious burns

When using this product

do not use longer than 1 week

Stop use and consult a doctor if

condition persists or gets worse
symptoms last for more than 7 days or clear up and come back within a few days
a rash or other allergic reaction develops

Keep out of the reach of children. If swallowed get medical help or contact a Poison Control Center immediately.

Directions

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

Other information

Store at a controlled room temperature 20º-25ºC (68° to 77°F)

Inactive ingredient

Petrolatum

Questions? Call; 1-800-222-1087

PRINCIPAL DISPLAY PANEL

Principal Display Panel – Carton Label

Leader Major NDC 70000-0093-1

Poly Bacitracin Zinc Ointment USP

Bacitracin Zinc 500 units

Polymixin B sulfate 10,000 units

First Aid Antibiotic Ointment

NET WT. 0.5 oz (14g)

PRINCIPAL DISPLAY PANEL

Principal Display Panel – Tube Label

Leader NDC 70000-0093-1

Poly Bacitracin Zinc Ointment

Bacitracin Zinc 500 Units

Polymixin B Sulfate 10,000 units

First Aid Antibiotic Ointment

Protection against Infection

NET WT. 0.5 oz ( 14g)

INGREDIENTS AND APPEARANCE

LEADER POLY BACITRACIN

first aid antibiotic ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70000-0093
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Bacitracin Zinc (UNII: 89Y4M234ES) (Bacitracin - UNII:58H6RWO52I)	Bacitracin	500 [USP'U] in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)	POLYMYXIN B	10000 [USP'U] in 1 g

Ingredient Name	Strength
Inactive Ingredients
Petrolatum (UNII: 4T6H12BN9U)

Product Characteristics
Color	yellow	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70000-0093-1	1 in 1 CARTON	06/01/2021
1		14 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	06/01/2021

Labeler - Cardinal Health 110, Inc. (063997360)

Registrant - Cardinal Health 110, Inc. (063997360)

Revised: 5/2021

Document Id: f0916063-f6cb-4160-96fb-f2362dd726dd

Set id: 442e11aa-7d14-44f9-bf14-446018f1de0d

Version: 1

Effective Time: 20210527

Search by Drug Name or NDC

NDC 70000-0093-01 Leader Poly Bacitracin 500; 10000 [USP'U]/g; [USP'U]/g Details

Leader Poly Bacitracin 500; 10000 [USP'U]/g; [USP'U]/g

Product Information

Package

Package Images

NDC 70000-0093-01 (70000009301)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 442e11aa-7d14-44f9-bf14-446018f1de0d Details

SPL UNCLASSIFIED SECTION

Active ingredients (In each gram)

Purpose

Uses

Warnings

Allergy alert:

Do not use

Consult a doctor before use if you have

When using this product

Stop use and consult a doctor if

Directions

Other information

Inactive ingredient

Questions? Call; 1-800-222-1087

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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