FDA.reportPublic FDA data

First Aid Antibiotic Bacitracin with Zinc

Manufacturer
First Aid Research Corp.
Effective date
2020-10-28
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:32:32

Label at a glance#

ProductFirst Aid Antibiotic Bacitracin with Zinc
Active ingredientBACITRACIN ZINC
Label structure15 sections

Storage and handling

Other information store at 15° to 25° C (59° to 77° F)

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (each gram contains)                                                                        

Bacitracin zinc        500 units

OTC - PURPOSE SECTION

Purpose

First Aid Antibiotic

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 - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

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.

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)

INACTIVE INGREDIENT SECTION

Inactive ingredients

aloe vera gel, light mineral oil and white petrolatum

SPL UNCLASSIFIED SECTION

Distributed by:

FIRST AID RESEARCH CORP.

Jupitor, FL 33478 Made in China

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

cartoncarton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

carton2carton2carton2carton2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1366116bacitracin zinc 500 UNT/GM Topical OintmentPSN4
1366116bacitracin zinc 0.5 UNT/MG Topical OintmentSCD4
1366116bacitracin zinc 500 UNT per GM Topical OintmentSY4

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75983-001-142023-01-30C16284748780-1f386c649-a82a-0266-e053-dadaa90a7c1aFirst Aid Research Bacitraycin Plus 1oz 49003 & 89770V (2019)
75983-001-282023-01-30C16284748780-1f386c649-a82a-0266-e053-dadaa90a7c1aFirst Aid Research Bacitraycin Plus 1oz 49003 & 89770V (2019)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75983-001-14First Aid Antibiotic Bacitracin with Zinc1 in 1 CARTONOINTMENT14
75983-001-14First Aid Antibiotic Bacitracin with Zinc14 g in 1 TUBEOINTMENT144
75983-001-28First Aid Antibiotic Bacitracin with Zinc1 in 1 CARTONOINTMENT14
75983-001-28First Aid Antibiotic Bacitracin with Zinc28 g in 1 TUBEOINTMENT284

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75983-001FIRST AID ANTIBIOTIC BACITRACIN WITH ZINC (BACITRACIN ZINC) OINTMENT [FIRST AID RESEARCH CORP.]4Legacy NDC, 4 package rows20201029_63f8b401-ccca-45ad-b23d-5ec81e2e8afb.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75983-00175983-001-14, 75983-001-28

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
LIGHT MINERAL OILN6K5787QVPIACT
ALOE VERA LEAFZY81Z83H0XIACT
PETROLATUM4T6H12BN9UIACT
BACITRACIN ZINC89Y4M234ESACTIM

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
b2c28f4b-5fea-6012-e053-2a95a90a664363f8b401-ccca-45ad-b23d-5ec81e2e8afb2020-10-28WarningsExact identifier
spl id: b2c28f4b-5fea-6012-e053-2a95a90a6643
spl set id: 63f8b401-ccca-45ad-b23d-5ec81e2e8afb

Reported adverse events (FAERS/openFDA)#

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