Search by Drug Name or NDC

NDC 11822-0044-05 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 Rite Aid Corporation. The primary component is BACITRACIN ZINC; POLYMYXIN B SULFATE.

Product Information

NDC	11822-0044
Product ID	11822-0044_b1abe61f-5d01-46fe-9482-f803d1463048
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
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	Rite Aid Corporation
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 11822-0044-05 (11822004405)

Pricing Information	N/A
NDC Package Code	11822-0044-5
Billing NDC	11822004405
Package	1 TUBE in 1 CARTON (11822-0044-5) / 14 g in 1 TUBE
Marketing Start Date	2022-02-25
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 1ef58b78-93ff-43d5-8254-492ca7648b33 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

Do not use

if you are allergic to any of the ingredients
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

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 the active ingredients in Polysporin®*

DOUBLE ANTIBIOTIC OINTMENT

BACITRACIN ZINC

POLYMYXIN B SULFATE OINTMENT, USP

FIRST AID ANTIBIOTIC

FOR EXTERNAL USE ONLY

HELPS PREVENT INFECTION

IN MINOR CUTS,

SCRAPES, AND BURNS

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

DISTRIBUTED BY:

RITE AID, 30 HUNTER LANE,

CAMP HILL, PA 17011

www.riteaid.com

Package label

Bacitracin Zinc, USP 500 units, Polymyxin B Sulfate, USP 10,000 units

RITE AID Double Antibiotic Ointment

INGREDIENTS AND APPEARANCE

ANTIBIOTIC

bacitracin zinc, polymyxin b sulfate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11822-0044
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:11822-0044-5	1 in 1 CARTON	02/25/2022
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	02/25/2022

Labeler - Rite Aid Corporation (014578892)

Revised: 2/2022

Document Id: b1abe61f-5d01-46fe-9482-f803d1463048

Set id: 1ef58b78-93ff-43d5-8254-492ca7648b33

Version: 1

Effective Time: 20220228