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NDC 51672-2027-01 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 Taro Pharmaceuticals U.S.A., Inc.. 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: 51672-2027-01
Last Updated: 11/30/2022
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: 51672-2027-01
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Pramoxine

Product Information

NDC	51672-2027
Product ID	51672-2027_4468ef01-b79c-4d45-8fa5-72650f732236
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	Taro Pharmaceuticals U.S.A., Inc.
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 51672-2027-01 (51672202701)

Pricing Information	N/A
NDC Package Code	51672-2027-1
Billing NDC	51672202701
Package	1 TUBE in 1 CARTON (51672-2027-1) / 14.2 g in 1 TUBE
Marketing Start Date	2012-03-31
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 4545c043-8e8e-4288-b4d8-e6ec9d72f979 Details

SPL UNCLASSIFIED SECTION

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

in the eyes
over large areas of the body
if you are allergic to any of the ingredients.

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
a 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 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. 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

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Label

First Aid Antibiotic

Pain Relieving Ointment

Maximum Strength

Triple Antibiotic

Ointment + Pain

Relief

Bacitracin Zinc ∙ Neomycin Sulfate

Polymyxin B Sulfate ∙ Pramoxine Hydrochloride

NET WT 1 oz (28.4 g)

Principal Display Panel - 28.4 g Tube Label

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:51672-2027
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:51672-2027-1	1 in 1 CARTON	03/31/2012
1		14.2 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:51672-2027-2	1 in 1 CARTON	03/31/2012
2		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	03/31/2012

Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370)

Name	Address	ID/FEI	Business Operations
Establishment
Taro Pharmaceuticals Inc.		206263295	MANUFACTURE(51672-2027)

Revised: 3/2019

Document Id: 4468ef01-b79c-4d45-8fa5-72650f732236

Set id: 4545c043-8e8e-4288-b4d8-e6ec9d72f979

Version: 3

Effective Time: 20190315