Lincoln

Manufacturer
Lincoln Pharmaceuticals Ltd.
Effective date
2016-04-05
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 ingredientHYDROCORTISONE ACETATE
Label structure12 sections

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Hydrocortisone Acetate USP (1 % W/W)

Drug Facts

OTC - PURPOSE SECTION

Anti-Itch

Drug Facts

WARNINGS SECTION

for external use only

INDICATIONS & USAGE SECTION

USES

  • For temporary relief of minor skin irritations, itching and rashes due to eczema, insect bites, poison ivy position sumac, poison oak, soaps, detergents, cosmetics, jewelry, and for external genital, feminine and anal itching. Other uses of this product should be only under the advice and supervision of a doctor

Drug Facts

OTC - DO NOT USE SECTION

  • in the eyes
  • for diaper rash
  • if you have a vaginal discharge
  • more than the recommended dosage

Drug Facts

OTC - ASK DOCTOR SECTION

If you are pregnant or breast- feeding

Drug Facts

OTC - STOP USE SECTION

  • the condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days

Drug Facts

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • If swallowed, get medical help or contact a Poison Control Center right away

Drug facts

DOSAGE & ADMINISTRATION SECTION

For Itching of skin irritation, inflammation and rashes:

  • adults and children over 2 years of age
  • apply evenly to affected area no more than 3 to 4 times daily

Children under 2 years of age

  • Do not use, consult a doctor

For External anal and genital itching, adults:

  • when practical cleanse the affected area with mild soap and warm water and rinse thoroughly
  • gently dry, patting or blotting with bathroom tissue or soft cloth before applying
  • apply externally to the area upto 6 times daily or after each bowel movement
  • after application, discard pad
  • do not flush in toilet

Drug Facts

INACTIVE INGREDIENT SECTION

Cetostearyl alcohol, chlorocresol, ceteth-20, edetate disodium, liquid paraffin, propylene glycol, purified water, sodium metabisulphite, white soft paraffin

Drug Facts:

OTHER SAFETY INFORMATION

  • store at room temperature 68-77 F (20°-25°C)
  • avoid excessive heat and humidity

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

principal display panelprincipal display panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1043690hydrocortisone acetate 1 % Topical CreamPSN1
1043690hydrocortisone acetate 10 MG/ML Topical CreamSCD1
1043690hydrocortisone acetate 1 % Topical CreamSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
HYDROCORTISONE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
15bd4439-874a-4934-9954-248e5455d460Product name120260310
9962b773-9f2e-22cc-0032-535e48ac417bProduct name320250724
56bb0587-1bf2-48b2-9d93-fc9f59d1eeb2Product name120250325
4d56e8eb-d741-d4a5-de3f-2bab1af75a60Product name720220608
626d7260-31b5-4412-84fd-579746adb6b3Product name120210513
8a011600-5e61-4c59-ab7b-54ab658a3b71Product name220181127
a919621a-248d-3c7a-1084-9f9ce286fdfdProduct name220181009
e7d5a174-836b-a0af-b014-cb0826c69ddcProduct name220181004
fcce390d-6460-4701-87cf-940d8800a1c3Product name220180212
bf065fa6-1e3b-e4c3-0bde-2dc842ceeea1Product name220150218
02657a3f-1489-66ea-f740-5ab9524e57d7Product name120140508
26f3d783-2cc1-4327-e77d-71804cf675a2Product name120140508
36fdc54c-bbeb-981e-8a53-4d768e283892Product name120140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
61e59a42-186b-9f4b-aec3-fb49a6debc31Product name120140508
705740e1-dee5-2610-c5a3-4c59cd9d62afProduct name120140508
7bdc4804-3832-c0df-e519-72b6d47c9792Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
abaf203f-619e-f265-559f-8c81af5cb1c2Product name120140508
acc4d8bb-0e29-e9f8-65f8-31e94184a9c0Product name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
bfd28ffb-d550-3fe9-f65b-10bcb7f971fdProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508
fe21f3fd-a378-0654-1972-db3c3b64470eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69636-3050-22020-01-31C16284748780-19d75b9cf-f40d-f424-e053-dadaa90a57ce2fbe9ae0-52d7-298a-e054-00144ff8d46c
69636-3050-32020-01-31C16284748780-19d75b9cf-f40d-f424-e053-dadaa90a57ce2fbe9ae0-52d7-298a-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69636-3050-2Lincoln0.9 g in 1 PACKETCREAM0.91
69636-3050-3Lincoln28.3 g in 1 TUBECREAM28.31

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69636-3050LINCOLN (HYDROCORTISONE ACETATE) CREAM [LINCOLN PHARMACEUTICALS LTD.]1Legacy NDC, 2 package rows20160409_2fbe9ae0-52d7-298a-e054-00144ff8d46c.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69636-305069636-3050-2, 69636-3050-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

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
2fbe9ae0-52d8-298a-e054-00144ff8d46c2fbe9ae0-52d7-298a-e054-00144ff8d46c2016-04-05WarningsExact identifier
spl id: 2fbe9ae0-52d8-298a-e054-00144ff8d46c
spl set id: 2fbe9ae0-52d7-298a-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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