FDA.reportPublic FDA data

Lincoln

Manufacturer
Lincoln Pharmaceuticals Ltd.
Effective date
2017-01-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:48:25

Label at a glance#

ProductLincoln
Active ingredientPETROLATUM
Label structure12 sections

Indications and uses

helps treat and prevent diaper rash helps seal out wetness temporarily protects minor cuts, scrapes, burns temporarily helps protect and relieve chapped and cracked skin or lips helps prevent and protect from the drying effects of wind and cold weather helps prevent and protect chafed skin in minor irritations associated with diaper rash with each diaper change, especially at bedtime when exposure to wet diapers m...

Dosage and administration

For Diaper Rash: change wet and soiled diaper promptly cleanse the diaper area allow to dry apply as needed

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

White Petrolatum USP (76% w/w)

PURPOSE

OTC - PURPOSE SECTION

Skin Protectant

USES

INDICATIONS & USAGE SECTION

  • helps treat and prevent diaper rash
  • helps seal out wetness
  • temporarily protects minor cuts, scrapes, burns
  • temporarily helps protect and relieve chapped and cracked skin or lips
  • helps prevent and protect from the drying effects of wind and cold weather
  • helps prevent and protect chafed skin in minor irritations associated with diaper rash
  • with each diaper change, especially at bedtime when exposure to wet diapers may be prolonged

WARNINGS:

WARNINGS SECTION

FOR EXTERNAL USE ONLY

When using this product:

OTC - WHEN USING SECTION

  • do not get into eyes

Stop Use and ask a doctor if

OTC - ASK DOCTOR SECTION

  • conditions worsens
  • symptoms last more than 7 days or clear up and occur again in a few days

Do not use on

OTC - DO NOT USE SECTION

  • deep or puncture wounds
  • 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

For Diaper Rash:

change wet and soiled diaper promptly
cleanse the diaper area allow to dry
apply as needed

OTHER INFORMATION

OTHER SAFETY INFORMATION

  • store at room temperature 15° - 30 °C (59-86 F)
  • avoid excessive heat and humidity

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

lanolin, lavender oil, light liquid paraffin, vitamin A, Vitamin D

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display and Drug Fact LabelPrincipal Display and Drug Fact Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049072petrolatum 76 % Topical OintmentPSN1
1049072petrolatum 0.76 MG/MG Topical OintmentSCD1
1049072petrolatum 76 % Topical OintmentSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69636-3045-22020-01-31C16284748780-19d75b9d0-4420-f424-e053-dadaa90a57ce45c37f14-ce76-523c-e054-00144ff88e88
69636-3045-32020-01-31C16284748780-19d75b9d0-4420-f424-e053-dadaa90a57ce45c37f14-ce76-523c-e054-00144ff88e88
69636-3045-42020-01-31C16284748780-19d75b9d0-4420-f424-e053-dadaa90a57ce45c37f14-ce76-523c-e054-00144ff88e88
69636-3045-52020-01-31C16284748780-19d75b9d0-4420-f424-e053-dadaa90a57ce45c37f14-ce76-523c-e054-00144ff88e88

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69636-3045-2Lincoln5 g in 1 PACKETOINTMENT51
69636-3045-3Lincoln28.3 g in 1 TUBEOINTMENT28.31
69636-3045-4Lincoln113 g in 1 TUBEOINTMENT1131
69636-3045-5Lincoln425 g in 1 JAROINTMENT4251

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69636-3045LINCOLN (WHITE PETROLATUM) OINTMENT [LINCOLN PHARMACEUTICALS LTD.]1Legacy NDC, 4 package rows20170111_45c37f14-ce76-523c-e054-00144ff88e88.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69636-304569636-3045-2, 69636-3045-3, 69636-3045-4, 69636-3045-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
PETROLATUM4T6H12BN9UACTIB
LAVENDER OILZBP1YXW0H8IACT
VITAMIN A81G40H8B0TIACT
VITAMIN D9VU1KI44GPIACT
LANOLIN7EV65EAW6HIACT
LIGHT MINERAL OILN6K5787QVPIACT

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
45c37f14-ce77-523c-e054-00144ff88e8845c37f14-ce76-523c-e054-00144ff88e882017-01-10WarningsExact identifier
spl id: 45c37f14-ce77-523c-e054-00144ff88e88
spl set id: 45c37f14-ce76-523c-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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