Galentic Triple Antibiotic Plus Pain Relief

Manufacturer
Galentic Pharma (India) Private Limited
Effective date
2020-10-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:10:04

Label at a glance#

ProductGalentic Triple Antibiotic Plus Pain Relief
Active ingredientBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE
Label structure8 sections

Label contents#

Full prescribing information#

Active Ingredients (in each gram)

OTC - ACTIVE INGREDIENT SECTION

Bacitracin Zinc 500 units

Neomycin Sulfate 3.5 mg

Polymyxin B Sulfate 10,000 units

Pramoxine HCl 10mg

OTC - PURPOSE SECTION

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

External Analgesic (Pramoxine HCl 10mg)

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

INDICATIONS & USAGE SECTION

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

WARNINGS 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

DOSAGE & ADMINISTRATION 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

INACTIVE INGREDIENT SECTION

White Petrolatum

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1 OZ (28 g) TUBE CARTON1 OZ (28 g) TUBE CARTON

Products#

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DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50382-05250382-052-13

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
98b72992-858d-22f6-e053-2a95a90a950f08e923b4-e3c1-4a20-a112-1b5176bfb2852020-10-24WarningsExact identifier
spl id: 98b72992-858d-22f6-e053-2a95a90a950f
spl set id: 08e923b4-e3c1-4a20-a112-1b5176bfb285

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.