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 ingredientZINC OXIDE
Label structure11 sections

Indications and uses

helps treat and prevent diaper rash temporarily protects minor cuts, scrapes, burns dries the oozing and weeping of poison ivy, poison oak, poison sumac

Dosage and administration

change wet and soiled diapers promptly cleanse the diaper area and allow to dry apply ointment liberally with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged for poison ivy, oak, and sumac apply ointment liberally as needed

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide (3.8% w/w)

PURPOSE

OTC - PURPOSE SECTION

Skin Protectant

USES

INDICATIONS & USAGE SECTION

  • helps treat and prevent diaper rash
  • temporarily protects minor cuts, scrapes, burns
  • dries the oozing and weeping of poison ivy, poison oak, poison sumac

WARNINGS

WARNINGS SECTION

FOR EXTERNAL USE ONLY

When using this product

OTC - WHEN USING SECTION

  • Do not get into the eyes

Stop use and ask a doctor

OTC - STOP USE SECTION

  • If condition worsens
  • symptoms last more than 7 days or clear up and occur again in a few days, consult a physician

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • if swallowed, get medical help or contact the Poison Control Center right away

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • change wet and soiled diapers promptly
  • cleanse the diaper area and allow to dry
  • apply ointment liberally with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged
  • for poison ivy, oak, and sumac
  • apply ointment liberally as needed

OTHER INFORMATION

OTHER SAFETY INFORMATION

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

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

aloe vera leaf, alpha-tocopherol, ceteth-10, cetostearyl alcohol, cetyl alcohol, cholecalciferol, glycerin, lanolin, lavender, methyl paraben, mineral oil, paraffin, petrolatum, phenoxyethanol, polyethylene glycol 6000, polysorbate 60, propylparaben sodium, steareth-20, trolamine, vitamin A, water, FD&C Yellow No. 5, D&C Red No. 21

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display & Drug Facts panelPrincipal Display & Drug Facts panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1865206zinc oxide 3.8 % Topical CreamPSN1
1865206zinc oxide 38 MG/ML Topical CreamSCD1
1865206zinc oxide 3.8 % Topical CreamSY1
1865206ZNO 38 MG/ML Topical CreamSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69636-3066-42020-01-31C16284748780-19d75b9d0-9cf4-f424-e053-dadaa90a57ce45c4d71e-99f8-18ce-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69636-3066-4Lincoln99.2 g in 1 TUBECREAM99.21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69636-3066LINCOLN (ZINC OXIDE) CREAM [LINCOLN PHARMACEUTICALS LTD.]1Legacy NDC, 1 package rows20170111_45c4d71e-99f8-18ce-e054-00144ff8d46c.zip

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69636-306669636-3066-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
CETYL ALCOHOL936JST6JCNIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
ALOE VERA LEAFZY81Z83H0XIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
LANOLIN7EV65EAW6HIACT
PROPYLPARABEN SODIUM625NNB0G9NIACT
STEARETH-20L0Q8IK9E08IACT
CETETH-10LF9X1PN3XJIACT
PETROLATUM4T6H12BN9UIACT
POLYETHYLENE GLYCOL 600030IQX730WEIACT
POLYSORBATE 60CAL22UVI4MIACT
TROLAMINE9O3K93S3TKIACT
VITAMIN A81G40H8B0TIACT
WATER059QF0KO0RIACT
D&C RED NO. 2108744Z6JNYIACT
GLYCERINPDC6A3C0OXIACT
LAVENDER OILZBP1YXW0H8IACT
METHYLPARABENA2I8C7HI9TIACT
MINERAL OILT5L8T28FGPIACT
PARAFFINI9O0E3H2ZEIACT
CHOLECALCIFEROL1C6V77QF41IACT
ZINC OXIDESOI2LOH54ZACTIB
PHENOXYETHANOLHIE492ZZ3TIACT
FD&C YELLOW NO. 5I753WB2F1MIACT

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
45c4d71e-99f9-18ce-e054-00144ff8d46c45c4d71e-99f8-18ce-e054-00144ff8d46c2017-01-10WarningsExact identifier
spl id: 45c4d71e-99f9-18ce-e054-00144ff8d46c
spl set id: 45c4d71e-99f8-18ce-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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