Galentic Triple Antibiotic Plus Pain Relief: Package Insert and Label Information

GALENTIC TRIPLE ANTIBIOTIC PLUS PAIN RELIEF- bacitracin zinc, neomycin sulfate, polymyxin b sulfate and pramoxine hydrochloride 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.

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

1 OZ (28 g) TUBE CARTON
(click image for full-size original)

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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BACITRACIN ZINC (BACITRACIN) BACITRACIN 500 [USP’U] in 1 g
NEOMYCIN SULFATE (NEOMYCIN) NEOMYCIN 3.5 mg in 1 g
POLYMYXIN B SULFATE (POLYMYXIN B) POLYMYXIN B 10000 [USP’U] in 1 g
PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE HYDROCHLORIDE 10 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
PETROLATUM
Product Characteristics
Color white Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50382-052-13 28 g in 1 TUBE None
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 Operations
Galentic Pharma (India) Private Limited 650970176 manufacture (50382-052), analysis (50382-052), pack (50382-052)

Revised: 10/2020 Galentic Pharma (India) Private Limited

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2022. All Rights Reserved.