FDA.reportPublic FDA data

LincoFix

Manufacturer
Lincoln Pharmaceuticals Ltd.
Effective date
2016-10-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:47:22

Label at a glance#

ProductLincoFix
Active ingredientLANOLIN
Label structure11 sections

Indications and uses

Helps prevent and temporarily protects chafed, chapped or cracked skin Temporarily protects minor cuts, scrapes, burns

Dosage and administration

Apply as needed to clean skin twice daily or more often if necessary For Children under 6 months ask a doctor

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Lanolin 22%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent and temporarily protects chafed, chapped or cracked skin
  • Temporarily protects minor cuts, scrapes, burns

Warnings

WARNINGS SECTION

FOR EXTERNAL USE ONLY

When using this product

OTC - WHEN USING SECTION

  • Avoid contact with eyes
  • If contact occurs, flush with water

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • symptoms last more than seven days or clear up and occur again within seven days

Do not use on

OTC - DO NOT USE SECTION

  • deep or puncture wounds
  • lacerations
  • animal bites
  • serious burns

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

Directions

DOSAGE & ADMINISTRATION SECTION

Apply as needed to clean skin twice daily or more often if necessary

  • For Children under 6 months ask a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aluminium Hydroxide, Alpha Tocopherol Acetate(Vitamin E), Calcium carbonate, Cholecalciferol (Vitamin D3), Citric Acid,Corn Oil, Ethylparaben, Lanolin, Magnesium Hydroxide, Methylparaben, Sodium Chloride, Sodium laureth Sulfate, Petrolatum, Vitamin A Palmitate, Water, Zinc Chloride

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Product LabelProduct Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1603511lanolin 22 % Topical OintmentPSN1
1603511lanolin 0.22 MG/MG Topical OintmentSCD1
1603511lanolin 22 % TopicalSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69636-8050-22020-01-31C16284748780-19d75b9d0-61f3-f424-e053-dadaa90a57ce3e20d989-cc33-2e15-e054-00144ff8d46c
69636-8050-32020-01-31C16284748780-19d75b9d0-61f3-f424-e053-dadaa90a57ce3e20d989-cc33-2e15-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69636-8050-2LincoFix113 g in 1 TUBEOINTMENT1131
69636-8050-3LincoFix113 g in 1 JAROINTMENT1131

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69636-8050LINCOFIX (LANOLIN) OINTMENT [LINCOLN PHARMACEUTICALS LTD.]1Legacy NDC, 2 package rows20161006_3e20d989-cc33-2e15-e054-00144ff8d46c.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69636-805069636-8050-2, 69636-8050-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
CORN OIL8470G57WFMIACT
ETHYLPARABEN14255EXE39IACT
LANOLIN ALCOHOLS884C3FA9HEIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
CALCIUM CARBONATEH0G9379FGKIACT
METHYLPARABENA2I8C7HI9TIACT
WATER059QF0KO0RIACT
LANOLIN7EV65EAW6HACTIB
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
CHOLECALCIFEROL1C6V77QF41IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
MAGNESIUM HYDROXIDENBZ3QY004SIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
PETROLATUM4T6H12BN9UIACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
ZINC CHLORIDE86Q357L16BIACT

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
3e20d989-cc34-2e15-e054-00144ff8d46c3e20d989-cc33-2e15-e054-00144ff8d46c2016-10-05WarningsExact identifier
spl id: 3e20d989-cc34-2e15-e054-00144ff8d46c
spl set id: 3e20d989-cc33-2e15-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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