CAREALL Hydrocortisone

Manufacturer
New World Imports, Inc
Effective date
2024-10-07
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:23:08

Label at a glance#

ProductCAREALL Hydrocortisone Maximum Strength
Active ingredientHydrocortisone Acetate
Label structure8 sections

Indications and uses

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

Dosage and administration

for itching of skin irritation, inflammation and rashes: 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.  Ask a doctor. For external anal and genital itching, adults: adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly.   Gently dry by patting or blotting with toliet tiss...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydrocortisone 1%

Purpose

OTC - PURPOSE SECTION

Anti-Itch

Keep out of reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center immediately.

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:

eczema, psoriasis, poison ivy, poison oak, poison sumac, insect bites, detergents, jewelry, seborrheic dermatitis, soaps, external itching 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

Do not use:

For the treatment of diaper rash.  Ask a doctor

In the genital if you have a vaginal discharge.  Consult a doctor

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 the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if:

Condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days and do not begin use of any other hydrocortisone product unless you have asked a doctor.

Rectal bleeding occurs

Directions

DOSAGE & ADMINISTRATION SECTION

for itching of skin irritation, inflammation and rashes:

  • Adults and children 2 years of age and olderapply to affected area not more than 3 to 4 times daily.
  • Children under 2 years of age do not use.  Ask a doctor.

For external anal and genital itching, adults:

  • adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly.  
  • Gently dry by patting or blotting with toliet tissue or a soft cloth before applying.
  • apply to affected area not more than 3 to 4 times daily.
  • children under 12 years of age with external anal itching: ask a doctor.

INACTIVE INGREDIENT SECTION

Cetamacrogol 1000, Cetostearyl Alcohol, Chlorocresol, Edetate Disodium, Liquid Paraffin, Propylene Glycol, Purified Water, White Soft Paraffin

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HYD1 CartonHYD1 Carton

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
51824-050-01CAREALL Hydrocortisone Maximum Strength28 g in 1 TUBECREAM287
51824-050-09CAREALL Hydrocortisone Maximum Strength.9 g in 1 PACKETCREAM.97
51824-050-14CAREALL Hydrocortisone Maximum Strength144 in 1 CONTAINERCREAM1447

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51824-050CAREALL HYDROCORTISONE MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [NEW WORLD IMPORTS, INC]7Current NDC, Legacy NDC, 3 package rows20241009_ea656cf8-cad5-4fa5-82e7-daec77a0bb04.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51824-050-01GM - Gram51824-050fe6ddcad-2e55-4288-b651-2bcb5a77576412020-03-10
51824-050-09EA - Each51824-05022b2e89d-523f-40d4-bff6-7430d185fb6512024-05-16
51824-050-14EA - Each51824-050854864d8-662f-4d23-a390-5b96f1a28c8812024-05-16

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51824-05051824-050-01, 51824-050-09, 51824-050-14

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 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
CAREALL Hydrocortisone Maximum StrengthHYDROCORTISONENew World Imports, Incea656cf8-cad5-4fa5-82e7-daec77a0bb042024-10-07WarningsExact identifier
ndc (package): 51824-050-14
ndc (package): 51824-050-01
ndc (package): 51824-050-09
ndc (product): 51824-050
ndc11 (package): 51824005014
ndc11 (package): 51824005001
ndc11 (package): 51824005009
spl id: d36efb97-adb6-41e5-a077-1ea4d711fb05
spl set id: ea656cf8-cad5-4fa5-82e7-daec77a0bb04

Reported adverse events (FAERS/openFDA)#

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