FDA.reportPublic FDA data

Astonea Triple Antibiotic Pain relief Ointment

Manufacturer
ASTONEA LABS PRIVATE LIMITED
Effective date
2023-12-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:09:21

Label at a glance#

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

Indications and uses

First Aid to help prevent infection and for temporary relief of pain in minor: Cuts Scrapes Burns

Dosage and administration

adults or children 2 years of age and older: Clean the affected area 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 doctor

Storage and handling

Store at 20° to 25°C (68° to 77°F) do not use if tube seal under cap is broken

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Bacitracin zinc 500 Units

Neomycin sulfate (3.5mg)

Polymyxin B sulfate (10000 units)

Pramoxine HCI (10mg)

Purpose

OTC - PURPOSE SECTION

First Aid Antibiotic

external analgesic

Uses

INDICATIONS & USAGE SECTION

First Aid to help prevent infection and for temporary relief of pain in minor:

  • Cuts
  • Scrapes
  • Burns

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

If you are allergic to any of the ingredients
In eyes
Over large areas of the body

Ask a Doctor before Use

OTC - ASK DOCTOR SECTION

Ask Doctor before use if you have:

  • Deep or puncture wouns
  • Animal bites
  • Serious burns

When using this product

OTC - WHEN USING SECTION

use only as directed

Stop Use and ask a Doctor if:

OTC - STOP USE SECTION

  • You need to use longer than 1 week
  • Condition persists or gets worse
  • rash or other allergic reaction develops

Keep out of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If Swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults or children 2 years of age and older:
  • Clean the affected area
  • 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 doctor

Other Information

STORAGE AND HANDLING SECTION

  • Store at 20° to 25°C (68° to 77°F)
  • do not use if tube seal under cap is broken

Inactive Ingredient:

INACTIVE INGREDIENT SECTION

White Petrolatum

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display and Drug Fact PanelPrincipal Display and Drug Fact Panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1359350bacitracin 500 UNT / neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG in GM Topical OintmentPSN1
1359350bacitracin 0.5 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 10 UNT/MG / pramoxine hydrochloride 0.01 MG/MG Topical OintmentSCD1
1359350bacitracin 500 UNT / neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical OintmentSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BACITRACIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
NEOMYCIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
POLYMYXIN B Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
99e684e6-f435-feb8-d2bb-3a546f1cb768Product name220161117
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0cProduct name120160603
2d352c73-a357-4193-a4de-dfdf9a2ac8e4Product name120150819
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
b6082387-f592-1148-0844-bd068fd213fbProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77338-229-01AstoneaTriple Antibiotic Pain Relief28.3 g in 1 TUBEOINTMENT28.31
77338-229-01AstoneaTriple Antibiotic Pain Relief1 in 1 BOXOINTMENT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77338-229ASTONEATRIPLE ANTIBIOTIC PAIN RELIEF (BACITRACIN,NEOMYCIN,POLYMXIN, PRAMOXINE) OINTMENT [ASTONEA LABS PRIVATE LIMITED]12 package rows20240305_0d81120b-f39e-bcde-e063-6294a90a70b7.zip

Products#

Every source-derived product name is available through these pages.

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77338-22977338-229-01

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
PETROLATUM4T6H12BN9UIACT
BACITRACIN ZINC89Y4M234ESACTIB
NEOMYCIN SULFATE057Y626693ACTIB
PRAMOXINE HYDROCHLORIDE88AYB867L5ACTIB
POLYMYXIN B SULFATE19371312D4ACTIM

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
0d8128c5-9bfb-c706-e063-6294a90a1aa00d81120b-f39e-bcde-e063-6294a90a70b72023-12-27WarningsExact identifier
spl id: 0d8128c5-9bfb-c706-e063-6294a90a1aa0
spl set id: 0d81120b-f39e-bcde-e063-6294a90a70b7

Reported adverse events (FAERS/openFDA)#

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