ProCure Hydrocortisone Cream Plus

Manufacturer
Rooftop Consumer Health, Inc.
Effective date
2026-01-29
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:35:41

Label at a glance#

ProductProCure Hydrocortisone Cream Plus
Active ingredientHYDROCORTISONE
Label structure8 sections

Indications and uses

• temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to: • eczema • psoriasis • poison ivy, oak, sumac • insect bites • detergents • jewelry • cosmetics • soaps • seborrheic dermatitis • other uses of this product should only be 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: ask a doctor

Label contents#

Full prescribing information#

Active ingredients (each gram contains)

OTC - ACTIVE INGREDIENT SECTION

Hydrocortisone 1%

Purpose

OTC - PURPOSE SECTION

Anti-itch

Uses

INDICATIONS & USAGE SECTION

• temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to: • eczema • psoriasis • poison ivy, oak, sumac • insect bites • detergents • jewelry • cosmetics • soaps • seborrheic dermatitis • other uses of this product should only be under the advice and supervision of a doctor.

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

• for the treatment of diaper rash. Ask a doctor.

When using this product

OTC - WHEN USING SECTION

• avoid contact with eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

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

• 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: ask a doctor

Other information

SPL UNCLASSIFIED SECTION

Store at controlled room temperature 68-77°F (20-25°C).

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Juice, Butylene Glycol, Calendula Officinalis Flower Extract, Caprylyl Glycol, Ceratonia Siliqua (Carob) Gum, Ceteareth-20, Cetearyl Alcohol, Chondrus Crispus (Carrageenan), Cocos Nucifera (Coconut) Oil, Ethylhexylglycerin, Glycerin, Glyceryl Stearate SE, Hexylene Glycol, Isopropyl Myristate, Olea Europaea (Olive) Fruit Oil, Phenoxyethanol

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-526-3668

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
106258hydrocortisone 1 % Topical CreamPSN5
106258hydrocortisone 10 MG/ML Topical CreamSCD5
106258hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical CreamSY5
106258hydrocortisone 1 % Topical CreamSY5
106258hydrocortisone 1 GM per 100 GM Topical CreamSY5

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
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
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
29784-142-28ProCure Hydrocortisone Cream Plus28 g in 1 TUBECREAM285
29784-142-28ProCure Hydrocortisone Cream Plus1 in 1 BOXCREAM15

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
29784-14229784-142-28

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 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
ProCure Hydrocortisone Cream PlusHYDROCORTISONERooftop Consumer Health, Inc.fe334cae-e019-4397-8498-df3c923ae8b52026-01-29WarningsExact identifier
ndc (package): 29784-142-28
ndc (product): 29784-142
ndc11 (package): 29784014228
spl id: 49880692-2d7f-80ed-e063-6394a90ae560
spl set id: fe334cae-e019-4397-8498-df3c923ae8b5

Reported adverse events (FAERS/openFDA)#

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