Triple Antibiotic Plus Pain Relief

Galentic Triple Antibiotic Plus Pain Relief by

Drug Labeling and Warnings

Galentic Triple Antibiotic Plus Pain Relief by is a Otc medication manufactured, distributed, or labeled by Galentic Pharma (India) Private Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

GALENTIC TRIPLE ANTIBIOTIC PLUS PAIN RELIEF- bacitracin zinc, neomycin sulfate, polymyxin b sulfate, pramoxine hcl ointment 
Galentic Pharma (India) Private Limited

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Triple Antibiotic Plus Pain Relief

Active Ingredients (in each gram)

Bacitracin Zinc 500 units

Neomycin Sulfate 3.5 mg

Polymyxin B Sulfate 10,000 units

Pramoxine HCl 10mg

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

External Analgesic (Pramoxine HCl 10mg)

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

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

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

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

White Petrolatum

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

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

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

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

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

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

Establishment
Name	Address	ID/FEI	Business Operations
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

34390-5

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

Version: 1

Effective Time: 20201024