First Aid Antibiotic Bacitraycin Plus Maximum Strength Ointment

Manufacturer
Anicare Pharmaceuticals Pvt. Ltd
Effective date
2020-12-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:35:12

Label at a glance#

ProductFirst Aid Antibiotic Bacitraycin Plus Maximum Strength
Active ingredientBACITRACIN, PRAMOXINE HYDROCHLORIDE
Label structure13 sections

Storage and handling

Other information store at 15° to 25° C (59° to 77° F) Lot No. & Exp. Date: see box or see crimp of tube

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (each gram contains)                                                                        

Bacitracin             500 units

Pramoxine HCl     10 mg

OTC - PURPOSE SECTION

Purpose

First Aid Antibiotic

Pain Reliever

INDICATIONS & USAGE SECTION

Uses

first aid to help prevent infection in

  • minor cuts
  • scrapes
  • burns

WARNINGS SECTION

Warnings

For external use only.

OTC - DO NOT USE SECTION

Do not use

  • in the eyes
  • over large areas of the body
  • if you are allergic to any of the ingredients
  • longer than 1 week unless directed by a doctor

OTC - ASK DOCTOR SECTION

Ask a doctor before use in case of deep or puncture wounds, animal bites, or serious burns.

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • the condition persists or gets worse
  • a rash or other allergic reaction develops

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

  • 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

STORAGE AND HANDLING SECTION

Other information

  • store at 15° to 25° C (59° to 77° F)
  • Lot No. & Exp. Date: see box or see crimp of tube

INACTIVE INGREDIENT SECTION

Inactive ingredients

aloe vera leaf,  methylparaben, mineral oil, petrolatum, propylparaben, stearyl alcohol

SPL UNCLASSIFIED SECTION

Distributed by:

First Aid Research Corp.

Jupiter, FL 33478

Made in India

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1303727bacitracin 500 UNT / pramoxine HCl 10 MG per GM Topical OintmentPSN1
1303727bacitracin 0.5 UNT/MG / pramoxine hydrochloride 0.01 MG/MG Topical OintmentSCD1
1303727bacitracin 500 UNT / pramoxine hydrochloride 10 MG per GM Topical OintmentSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BACITRACIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2d352c73-a357-4193-a4de-dfdf9a2ac8e4Product name120150819
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
47046-163-022022-01-28C16284748780-1d6a99b3a-0090-a426-e053-dadaa90af4c2First Aid Antibiotic Bacitraycin Plus Maximum Strength Ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47046-163-01First Aid Antibiotic Bacitraycin Plus Maximum Strength28 g in 1 TUBEOINTMENT281
47046-163-02First Aid Antibiotic Bacitraycin Plus Maximum Strength1 in 1 CARTONOINTMENT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47046-163FIRST AID ANTIBIOTIC BACITRAYCIN PLUS MAXIMUM STRENGTH (BACITRACIN AND PRAMOXINE HCL) OINTMENT [ANICARE PHARMACEUTICALS PVT. LTD]1Legacy NDC, 2 package rows20201215_b65ee2ed-b506-7bcf-e053-2995a90ae10a.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
47046-16347046-163-01, 47046-163-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 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
b65eeccf-48e8-6769-e053-2a95a90a1956b65ee2ed-b506-7bcf-e053-2995a90ae10a2020-12-13WarningsExact identifier
spl id: b65eeccf-48e8-6769-e053-2a95a90a1956
spl set id: b65ee2ed-b506-7bcf-e053-2995a90ae10a

Reported adverse events (FAERS/openFDA)#

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