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NDC 62011-0099-01 Triple Antibiotic Plus Pain Relief 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g Details

Triple Antibiotic Plus Pain Relief 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g

Triple Antibiotic Plus Pain Relief is a TOPICAL OINTMENT in the HUMAN OTC DRUG category. It is labeled and distributed by Strategic Sourcing Services LLC. The primary component is BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE.

MedlinePlus Drug Summary

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

Related Packages: 62011-0099-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Neomycin, Polymyxin, and Bacitracin Topical

Pramoxine is used to temporarily relieve pain and itching from insect bites; poison ivy, poison oak, or poison sumac; minor cuts, scrapes, or burns; minor skin irritation or rashes; or dry, itchy skin. Pramoxine also may be used to treat soreness, burning, itching, and pain from hemorrhoids (''piles'') and other minor rectal irritations or itching. Pramoxine is in a class of medications called topical anesthetics. It works by stopping nerves from sending pain signals.

Related Packages: 62011-0099-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Pramoxine

Product Information

NDC	62011-0099
Product ID	62011-0099_4750a2f4-db4b-4980-ab5e-e29c64902510
Associated GPIs	90109804434220
GCN Sequence Number	047690
GCN Sequence Number Description	neomycn/bacitrc/polymyx/pramox OINT. (G) 3.5-10K-10 TOPICAL
HIC3	Q5W
HIC3 Description	TOPICAL ANTIBIOTICS
GCN	12623
HICL Sequence Number	035595
HICL Sequence Number Description	NEOMYCIN SULF/BACITRACIN ZINC/POLYMYXIN B SULF/PRAMOXINE HCL
Brand/Generic	Generic
Proprietary Name	Triple Antibiotic Plus Pain Relief
Proprietary Name Suffix	n/a
Non-Proprietary Name	Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride
Product Type	HUMAN OTC DRUG
Dosage Form	OINTMENT
Route	TOPICAL
Active Ingredient Strength	500; 3.5; 10000; 10
Active Ingredient Units	[USP'U]/g; mg/g; [USP'U]/g; mg/g
Substance Name	BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE
Labeler Name	Strategic Sourcing Services LLC
Pharmaceutical Class	Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], 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 62011-0099-01 (62011009901)

Pricing Information
NDC Package Code	62011-0099-1
Billing NDC	62011009901
Package	1 TUBE in 1 CARTON (62011-0099-1) / 28.4 g in 1 TUBE
Marketing Start Date	2012-03-12
NDC Exclude Flag	N
Price Per Unit	0.1262
Pricing Unit	GM
Effective Date	2024-02-21
NDC Description	HM TRIPLE ANTIBIOTIC PLUS OINT
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1, 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 bedc0643-c5a1-4199-88ea-dee86d8fda5b Details

SPL UNCLASSIFIED SECTION

Drug Facts

SPL UNCLASSIFIED SECTION

Active ingredients (in each gram)	Purpose
Bacitracin zinc USP 500 units	First aid antibiotic
Neomycin sulfate USP 3.5 mg	First aid antibiotic
Polymyxin B sulfate USP 10,000 units	First aid antibiotic
Pramoxine HCl USP 10 mg	External analgesic

Uses

first aid to help prevent infection and for the temporary relief of pain or discomfort in minor:

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
symptoms persist for more than 1 week, or clear up and occur again within a few days
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

adults and children 2 years of age and older:
- 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
children under 2 years of age: ask a doctor

Other information

To open: unscrew cap, pull tab to remove foil seal
store at 20° to 25°C (68° to 77°F)
see carton or tube crimp for lot number and expiration date

Inactive ingredient

white petrolatum

Questions?

Call 1-866-923-4914

SPL UNCLASSIFIED SECTION

Distributed by McKesson

One Post Street, San Francisco, CA 94104

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

Health Mart®

FIRST AID

Triple Antibiotic Ointment

plus pain relief

• bacitracin zinc • neomycin sulfate • polymyxin B sulfate • pramoxine hydrochloride

Antibiotic Ointment

NET WT 1 oz (28.4 g)

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

INGREDIENTS AND APPEARANCE

TRIPLE ANTIBIOTIC PLUS PAIN RELIEF

bacitracin zinc, neomycin sulfate, polymyxin b sulfate, and pramoxine hydrochloride ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:62011-0099
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
Neomycin Sulfate (UNII: 057Y626693) (Neomycin - UNII:I16QD7X297)	Neomycin Sulfate	3.5 mg in 1 g
Polymyxin B Sulfate (UNII: 19371312D4) (Polymyxin B - UNII:J2VZ07J96K)	Polymyxin B	10000 [USP'U] in 1 g
Pramoxine Hydrochloride (UNII: 88AYB867L5) (Pramoxine - UNII:068X84E056)	Pramoxine Hydrochloride	10 mg in 1 g

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:62011-0099-1	1 in 1 CARTON	03/12/2012
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	03/12/2012

Labeler - Strategic Sourcing Services LLC (116956644)

Name	Address	ID/FEI	Business Operations
Establishment
Taro Pharmaceuticals Inc.		206263295	MANUFACTURE(62011-0099)

Revised: 11/2019

Document Id: 4750a2f4-db4b-4980-ab5e-e29c64902510

Set id: bedc0643-c5a1-4199-88ea-dee86d8fda5b

Version: 4

Effective Time: 20191108

Search by Drug Name or NDC

NDC 62011-0099-01 Triple Antibiotic Plus Pain Relief 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g Details

Triple Antibiotic Plus Pain Relief 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 62011-0099-01 (62011009901)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL bedc0643-c5a1-4199-88ea-dee86d8fda5b Details

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Uses

Warnings

Do not use

Ask a doctor before use if you have

Stop use and ask a doctor if

Directions

Other information

Inactive ingredient

Questions?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

INGREDIENTS AND APPEARANCE

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