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NDC 70000-0471-01 Poly Bacitracin 500; 10000 [USP'U]/g; [USP'U]/g Details

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

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

Product Information

NDC	70000-0471
Product ID	70000-0471_edc20f71-028e-1f15-e053-2a95a90a13a6
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	Poly Bacitracin
Proprietary Name Suffix	n/a
Non-Proprietary Name	First Aid Antibiotic Ointment
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
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	2023-12-31

Package

Package Images

NDC 70000-0471-01 (70000047101)

Pricing Information
NDC Package Code	70000-0471-1
Billing NDC	70000047101
Package	72 BOX in 1 CASE (70000-0471-1) / 1 TUBE in 1 BOX / 28.4 g in 1 TUBE
Marketing Start Date	2018-11-20
NDC Exclude Flag	N
Price Per Unit	0.08294
Pricing Unit	GM
Effective Date	2022-03-23
NDC Description	POLY BACITRACIN OINTMENT
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1, 5
Classification for Rate Setting	G
As of Date	2022-03-23

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 7ffa5623-53dd-2f8d-e053-2a91aa0a9257 Details

Active Ingredient

Bacitracin zinc 500 units (in one gram)

Purpose

First Aid Antibiotic

Active Ingredients

Polymyxin B sulfate 10,000 units (in one gram)

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, longer than one week

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 one week, condition persists or gets worse, rash or other allergic reaction develops

If swallowed, get medical help or contact a Poison Control Center (1800-222-1222) right away.

Directions

clean the affected area and dry thoroughly, 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 room temperature

Inactive Ingredients

white petrolatum

Questions and comments?

1-888-396-2739

Label

INGREDIENTS AND APPEARANCE

POLY BACITRACIN

first aid antibiotic ointment ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70000-0471
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN ZINC	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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70000-0471-1	72 in 1 CASE	11/20/2018
1		1 in 1 BOX
1		28.4 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	11/20/2018

Labeler - Cardinal Health (063997360)

Registrant - Dynarex Corporation (008124539)

Revised: 11/2022

Document Id: edc20f71-028e-1f15-e053-2a95a90a13a6

Set id: 7ffa5623-53dd-2f8d-e053-2a91aa0a9257

Version: 6

Effective Time: 20221118

Search by Drug Name or NDC

NDC 70000-0471-01 Poly Bacitracin 500; 10000 [USP'U]/g; [USP'U]/g Details

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

Product Information

Package

Package Images

NDC 70000-0471-01 (70000047101)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 7ffa5623-53dd-2f8d-e053-2a91aa0a9257 Details

Active Ingredient

Purpose

Active Ingredients

Purpose

Uses

Warnings

Do not use

Ask a doctor before use if you have

Stop use and ask a doctor if

Directions

Other Information

Inactive Ingredients

Questions and comments?

Label

INGREDIENTS AND APPEARANCE

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