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NDC 50382-0052-13 Galentic Triple Antibiotic Plus Pain Relief 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g Details

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

Galentic Triple Antibiotic Plus Pain Relief is a TOPICAL OINTMENT in the HUMAN OTC DRUG category. It is labeled and distributed by Galentic Pharma (India) Private Limited. 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: 50382-0052-13
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: 50382-0052-13
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Pramoxine

Product Information

NDC	50382-0052
Product ID	50382-052_98b72992-858d-22f6-e053-2a95a90a950f
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	Galentic Triple Antibiotic Plus Pain Relief
Proprietary Name Suffix	n/a
Non-Proprietary Name	Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, Pramoxine HCl
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	Galentic Pharma (India) Private Limited
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	2023-12-31

Package

Package Images

NDC 50382-0052-13 (50382005213)

Pricing Information	N/A
NDC Package Code	50382-052-13
Billing NDC	50382005213
Package	28 g in 1 TUBE (50382-052-13)
Marketing Start Date	2019-12-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 08e923b4-e3c1-4a20-a112-1b5176bfb285 Details

Active Ingredients (in each gram)

Bacitracin Zinc 500 units

Neomycin Sulfate 3.5 mg

Polymyxin B Sulfate 10,000 units

Pramoxine HCl 10mg

SPL UNCLASSIFIED SECTION

First aid antibiotic (Bacitracin Zinc 500 units, Neomycin Sulfate 3.5 mg, & Polymyxin B Sulfate 10,000 units)

External Analgesic (Pramoxine HCl 10mg)

SPL UNCLASSIFIED SECTION

If swallowed, get medical help or contact a poison control center immediately

SPL UNCLASSIFIED SECTION

First aid to help prevent infection and for temporary relief of pain in minor cuts, scrapes and burns

SPL UNCLASSIFIED SECTION

For external use only

Do not use

In the eyes

If you are allergic to any of the ingredients

Over large areas of the body

Ask a doctor before use if you have

Animal bites

Serious Burns

Deep or puncture wounds

Stop use and ask a doctor if

You need to use longer than 1 week

condition persists or gets worse

rash or other allergic reaction develops

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

SPL UNCLASSIFIED SECTION

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 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

SPL UNCLASSIFIED SECTION

White Petrolatum

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GALENTIC TRIPLE ANTIBIOTIC PLUS PAIN RELIEF

bacitracin zinc, neomycin sulfate, polymyxin b sulfate, pramoxine hcl ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50382-052
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN	500 [USP'U] in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)	NEOMYCIN	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)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50382-052-13	28 g in 1 TUBE; Type 0: Not a Combination Product	12/15/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333B	02/28/2019

Labeler - Galentic Pharma (India) Private Limited (915110464)

Name	Address	ID/FEI	Business Operations
Establishment
Galentic Pharma (India) Private Limited		650970176	manufacture(50382-052) , analysis(50382-052) , pack(50382-052)

Revised: 10/2020

Document Id: 98b72992-858d-22f6-e053-2a95a90a950f

Set id: 08e923b4-e3c1-4a20-a112-1b5176bfb285

Version: 1

Effective Time: 20201024

Search by Drug Name or NDC

NDC 50382-0052-13 Galentic Triple Antibiotic Plus Pain Relief 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g Details

Galentic 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 50382-0052-13 (50382005213)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 08e923b4-e3c1-4a20-a112-1b5176bfb285 Details

Active Ingredients (in each gram)

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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