FDA.reportPublic FDA data

First Aid Maximum Strength Bacitraycin Plus Ointment 1oz 49555 (2018)

Manufacturer
First Aid Research Corp
Effective date
2018-03-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:54:50

Label at a glance#

ProductFirst Aid Maximum Strength Bacitraycin Plus
Active ingredientBACITRACIN, PRAMOXINE HYDROCHLORIDE
Label structure12 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 ingredients (each gram contains) Purpose

Bacitracin 500 units.......................................................................................................First Aid Antibiotic

Pramoxine HCI 10 mg..................................................................................................Pain Reliever

OTC - PURPOSE 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
  • if you are allergic to any of the ingredients
  • over large areas of the body
  • 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 - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away

INDICATIONS & USAGE 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

DOSAGE & ADMINISTRATION SECTION

Distributed by:

First Aid Research Corp.

Jupiter, FL 33478

Made in Korea

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

4955549555

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

89884V89884V

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
75983-055-282022-01-28C16284748780-1d6a99b39-342b-a426-e053-dadaa90af4c2First Aid Maximum Strength Bacitraycin Plus Ointment 1oz 49555 (2018)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75983-055-28First Aid Maximum Strength Bacitraycin Plus1 in 1 CARTONOINTMENT11
75983-055-28First Aid Maximum Strength Bacitraycin Plus28 g in 1 TUBEOINTMENT281

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75983-055FIRST AID MAXIMUM STRENGTH BACITRAYCIN PLUS (BACITRACIN, AND PRAMOXINE HCL) OINTMENT [FIRST AID RESEARCH CORP]1Legacy NDC, 2 package rows20180303_6664713c-8be2-38c4-e053-2991aa0a7772.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
75983-05575983-055-28

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
METHYLPARABENA2I8C7HI9TIACT
ALOE VERA LEAFZY81Z83H0XIACT
MINERAL OILT5L8T28FGPIACT
BACITRACIN58H6RWO52IACTIB
PRAMOXINE HYDROCHLORIDE88AYB867L5ACTIB
PETROLATUM4T6H12BN9UIACT
PROPYLPARABENZ8IX2SC1OHIACT
STEARYL ALCOHOL2KR89I4H1YIACT

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
6664713c-8be3-38c4-e053-2991aa0a77726664713c-8be2-38c4-e053-2991aa0a77722018-03-01WarningsExact identifier
spl id: 6664713c-8be3-38c4-e053-2991aa0a7772
spl set id: 6664713c-8be2-38c4-e053-2991aa0a7772

Reported adverse events (FAERS/openFDA)#

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