Maximum Strength Hydrocortisone

Manufacturer
DLC Laboratories, Inc
Effective date
2026-01-07
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:31:51

Label at a glance#

ProductMaximum Strength Hydrocortisone
Active ingredientHYDROCORTISONE
Label structure11 sections

Indications and uses

for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis for external genital, feminine and anal itching other uses of this product should be only under the advice and supervision of a doctor

Dosage and administration

Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: do not use. Consult a doctor. Adults: for external anal itching: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product Children under 12 yea...

Storage and handling

store at room temperature

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydrocortisone, USP 1%

Purpose

OTC - PURPOSE SECTION

Antipruritic (Anti-itch)

Uses

INDICATIONS & USAGE SECTION

  • for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis
  • for external genital, feminine and anal itching
  • other uses of this product should be only under the advice and supervision of a doctor

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use

  • for the treatment of diaper rash. Consult a doctor.
  • for external feminine itching if you have a vaginal discharge. Consult a doctor.

OTC - WHEN USING SECTION

When using this product

  • avoid contact with the eyes
  • do not use more than directed unless told to do so by a doctor
  • do not put this product into rectum by using fingers or any mechanical device or applicator

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days. Do not begin use of any other hydrocortisone product unless you have consulted a doctor.
  • rectal bleeding occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF THE REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

SPL UNCLASSIFIED SECTION

Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily.

Children under 2 years of age: do not use. Consult a doctor.

SPL UNCLASSIFIED SECTION

Adults: for external anal itching:

  • when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly
  • gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product

Children under 12 years of age: for external anal itching, consult a doctor

Other information

STORAGE AND HANDLING SECTION

  • store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

mineral oil, petrolatum

Questions

OTC - QUESTIONS SECTION

1-800-858-3889

SPL UNCLASSIFIED SECTION

Distributed by:

De La Cruz Products
A Division of DLC Laboratories, Inc.
Paramount, CA 90723 USA

PRINCIPAL DISPLAY PANEL - 28 g Tube Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

De La Cruz ®

Anti-Itch

Ointment

Maximum Strength

Hydrocortisone 1%

For Relief of Itching, Rashes

and Skin Irritations

  • Fragrance Free
  • Rapid Relief

Net Wt. 1 OZ (28g)

Hydrocortisone-01Hydrocortisone-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
203105hydrocortisone 1 % Topical OintmentPSN6
203105hydrocortisone 0.01 MG/MG Topical OintmentSCD6
203105hydrocortisone 1 % Topical OintmentSY6

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24286-1560-1Maximum Strength Hydrocortisone1 in 1 BOXOINTMENT16
24286-1560-1Maximum Strength Hydrocortisone28 g in 1 TUBEOINTMENT286

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
HYDROCORTISONEACTIVE INGREDIENTWI4X0X7BPJ1
HYDROCORTISONEACTIVE MOIETYWI4X0X7BPJ1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGP1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9U1

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
24286-156024286-1560-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
MINERAL OILT5L8T28FGPIACT
PETROLATUM4T6H12BN9UIACT
HYDROCORTISONEWI4X0X7BPJACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 4 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
MINERAL OILMINERAL OILT5L8T28FGPOINTMENT / TOPICAL9938 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / TOPICAL7275 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / TOPICAL7275 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPOINTMENT / TOPICAL9938 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates

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
Maximum Strength HydrocortisoneHYDROCORTISONEDLC Laboratories, Inccaf50f12-f35c-4e9e-8ef7-3b0c84e225ee2026-01-07WarningsExact identifier
ndc (package): 24286-1560-1
ndc (product): 24286-1560
ndc11 (package): 24286156001
spl id: 47d50931-ec8a-bab5-e063-6394a90a6e6b
spl set id: caf50f12-f35c-4e9e-8ef7-3b0c84e225ee

Reported adverse events (FAERS/openFDA)#

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