FDA.reportPublic FDA data

Lincoln

Manufacturer
Lincoln Pharmaceuticals Ltd. | Lincoln Pharmaceuticals Ltd
Effective date
2016-04-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:45:40

Label at a glance#

ProductLincoln
Active ingredientBACITRACIN ZINC
Label structure9 sections

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient (in each gram)

Bacitracin Zinc (equal to 500 bacitracin units)

Drug Facts

OTC - PURPOSE SECTION

First Aid Antibiotic

Drug Facts

INDICATIONS & USAGE SECTION

Uses

  • first aid to help prevent infection in minor
  • cuts scrapes
  • burns

Drug Facts

WARNINGS SECTION

For External use only

Do not use

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

Drug Facts

OTC - ASK DOCTOR SECTION

  • deep or puncture wounds
  • animal bites
  • serious burns

Drug Facts

OTC - STOP USE SECTION

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

Drug Facts

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

Drug Facts

DOSAGE & ADMINISTRATION SECTION

  • clean the affected area
  • apply a small amount of this product (an amount equals 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

Drug Facts

OTHER SAFETY INFORMATION

Other information:

  • store at controlled temperature 15°-30° C
  • Avoid excessive heat and humidity

Drug Facts

INACTIVE INGREDIENT SECTION

Inactive ingredients

hard paraffin, liquid paraffin, white soft paraffin, lanolin

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

principal displayprincipal display

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1366116bacitracin zinc 500 UNT/GM Topical OintmentPSN1
1366116bacitracin zinc 0.5 UNT/MG Topical OintmentSCD1
1366116bacitracin zinc 500 UNT 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69636-3035-22020-01-31C16284748780-19d75b9d0-4bf7-f424-e053-dadaa90a57ce2fb062c7-d75e-4c42-e054-00144ff88e88
69636-3035-32020-01-31C16284748780-19d75b9d0-4bf7-f424-e053-dadaa90a57ce2fb062c7-d75e-4c42-e054-00144ff88e88
69636-3035-42020-01-31C16284748780-19d75b9d0-4bf7-f424-e053-dadaa90a57ce2fb062c7-d75e-4c42-e054-00144ff88e88
69636-3035-52020-01-31C16284748780-19d75b9d0-4bf7-f424-e053-dadaa90a57ce2fb062c7-d75e-4c42-e054-00144ff88e88
69636-3035-62020-01-31C16284748780-19d75b9d0-4bf7-f424-e053-dadaa90a57ce2fb062c7-d75e-4c42-e054-00144ff88e88

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69636-3035-2Lincoln0.9 g in 1 PACKETOINTMENT0.91
69636-3035-3Lincoln14 g in 1 TUBEOINTMENT141
69636-3035-4Lincoln28 g in 1 TUBEOINTMENT281
69636-3035-5Lincoln113 g in 1 TUBEOINTMENT1131
69636-3035-6Lincoln425 g in 1 JAROINTMENT4251

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69636-3035LINCOLN (BACITRACIN ZINC) OINTMENT [LINCOLN PHARMACEUTICALS LTD.]1Legacy NDC, 5 package rows20160409_2fb062c7-d75e-4c42-e054-00144ff88e88.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69636-303569636-3035-2, 69636-3035-3, 69636-3035-4, 69636-3035-5, 69636-3035-6

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
MINERAL OILT5L8T28FGPIACT
LANOLIN7EV65EAW6HIACT
PETROLATUM4T6H12BN9UIACT
PARAFFINI9O0E3H2ZEIACT
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
2fb062c7-d75f-4c42-e054-00144ff88e882fb062c7-d75e-4c42-e054-00144ff88e882016-04-08WarningsExact identifier
spl id: 2fb062c7-d75f-4c42-e054-00144ff88e88
spl set id: 2fb062c7-d75e-4c42-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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