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NDC 70000-0070-01 Antibiotic 500; 10000 [iU]/g; [iU]/g Details

Antibiotic 500; 10000 [iU]/g; [iU]/g

Antibiotic is a TOPICAL OINTMENT in the HUMAN OTC DRUG category. It is labeled and distributed by Cardinal Health (Leader) 70000. The primary component is BACITRACIN ZINC; POLYMYXIN B SULFATE.

Product Information

NDC	70000-0070
Product ID	70000-0070_2d1ce8ad-b2bb-4a42-bfbb-1edc9d4634db
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	Antibiotic
Proprietary Name Suffix	n/a
Non-Proprietary Name	Bacitracin Zinc, Polymyxin B Sulfate
Product Type	HUMAN OTC DRUG
Dosage Form	OINTMENT
Route	TOPICAL
Active Ingredient Strength	500; 10000
Active Ingredient Units	[iU]/g; [iU]/g
Substance Name	BACITRACIN ZINC; POLYMYXIN B SULFATE
Labeler Name	Cardinal Health (Leader) 70000
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 70000-0070-01 (70000007001)

Pricing Information	N/A
NDC Package Code	70000-0070-1
Billing NDC	70000007001
Package	1 TUBE in 1 CARTON (70000-0070-1) / 28 g in 1 TUBE
Marketing Start Date	2020-12-31
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 1280ce90-133a-472b-bfd7-107b9621deda Details

Drug Facts

Active ingredients (in each gram)

Bacitracin zinc, USP 500 units

Polymyxin B sulfate, USP 10,000 units

Purpose

First aid antibiotic

Uses

First aid to help prevent infection in

cuts
scrapes
burns

Warnings

For external use only

Allergy alert:

do not use if allergic to any of the ingredients

Do not use

in the eyes
over large areas of the body

Ask 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 unless directed by a doctor

Stop use and ask a doctor if

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

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

clean 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 15º-25ºC (59º-77ºF)
Before using any medication, read all label directions. Keep carton, it contains important information.

Inactive ingredient

white petrolatum

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal display panel

COMPARE TO POLYSPORN® active ingredients*

For External Use Only

Dual Action

First Aid to Help Prevent Infection in

Minor Cuts, Scrapes, and Burns

Protection Against Infection

Poly Bacitracin

Bacitracin Zinc USP | Polymyxin B Sulfate

First Aid Antibiotic Ointment

*This product is not manufactured or distributed by Johnson & Johnson Consumer, Inc., distributor of Polysporin®.

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com

Package label

Bacitrain zinc, USP 500 units, Polymyxin B sulfate, USP 10,000 Units

LEADER Poly Bacitrain

INGREDIENTS AND APPEARANCE

ANTIBIOTIC

bacitracin zinc, polymyxin b sulfate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70000-0070
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN	500 [iU] in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)	POLYMYXIN B	10000 [iU] in 1 g

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70000-0070-1	1 in 1 CARTON	12/31/2020
1		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	12/31/2020

Labeler - Cardinal Health (Leader) 70000 (063997360)

Revised: 10/2022

Document Id: 2d1ce8ad-b2bb-4a42-bfbb-1edc9d4634db

Set id: 1280ce90-133a-472b-bfd7-107b9621deda

Version: 3

Effective Time: 20221020