Cortizone 10 Ultra Soothing Itch Relief Cream

Manufacturer
Chattem, Inc.
Effective date
2025-02-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:56:52

Label at a glance#

ProductCortizone 10 Ultra Soothing Itch Relief
Active ingredientHYDROCORTISONE
Label structure8 sections

Indications and uses

■ for the temporary relief of 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 ■   temporarily relieves external anal and genital itching ■   other uses of this product should be only under the advice and supervision of a do...

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: ask a doctor ■   for external anal and genital itching, adults       ■   when practical, clean the affected area with mild soap and warm water and rinse thoroughly       ■   gently dry by patting or blo...

Label contents#

Full prescribing information#

     

SPL UNCLASSIFIED SECTION

Cortizone 10 Ultra Soothing Itch Relief Cream

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Hydrocortisone 1%

Purpose

OTC - PURPOSE SECTION

Anti-Itch

Uses

INDICATIONS & USAGE SECTION

■ for the temporary relief of 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

■ temporarily relieves external anal and genital 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

OTC - DO NOT USE SECTION

■ in the genital area if you have a vaginal discharge. Consult a doctor. ■ for the treatment of diaper rash. Consult a doctor.

When using this product 

OTC - WHEN USING SECTION

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

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, and do not begin use of any other hydrocortisone product unless you have asked a doctor

■ rectal bleeding occurs

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

■ 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: ask a doctor

■ for external anal and genital itching, adults

      ■  when practical, clean 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 applying
      ■  apply to affected area not more than 3 to 4 times daily
      ■  children under 12 years of age: ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, cetearyl alcohol, glycerin, petrolatum, mineral oil, isopropyl palmitate, sodium lauryl sulfate, beeswax, sodium cetearyl sulfate, methylparaben, tocopheryl acetate, propylparaben, propylene glycol, cetyl alcohol, aluminum sulfate, calcium acetate, dextrin, zea mays (corn) oil, cholecalciferol, retinyl palmitate, aloe barbadensis leaf juice, maltodextrin

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAXIMUM STRENGTH
Cortizone 10
ULTRA SOOTHING
ITCH RELIEF
CREAM
1% Hydrocortisone
Anti-Itch Cream
Net wt 1 oz (28 g)

MAXIMUM STRENGTH Cortizone 10 ULTRA SOOTHING ITCH RELIEF CREAM 1% Hydrocortisone Anti-Itch Cream Net wt 1 oz (28 g)MAXIMUM STRENGTH Cortizone 10 ULTRA SOOTHING ITCH RELIEF CREAM 1% Hydrocortisone Anti-Itch Cream Net wt 1 oz (28 g)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
206352Cortizone-10 1 % Topical CreamPSN1
106258hydrocortisone 1 % Topical CreamPSN1
206352hydrocortisone 10 MG/ML Topical Cream [Cortizone]SBD1
106258hydrocortisone 10 MG/ML Topical CreamSCD1
206352Cortizone 1 % Topical CreamSY1
206352Cortizone 10 MG/ML Topical CreamSY1
106258hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical CreamSY1
106258hydrocortisone 1 % Topical CreamSY1
106258hydrocortisone 1 GM per 100 GM 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
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
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
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
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
60c52429-fcef-eb54-2387-43bc9e4f296bProduct 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
41167-0029-0Cortizone 10 Ultra Soothing Itch Relief1 in 1 CARTONCREAM11
41167-0029-0Cortizone 10 Ultra Soothing Itch Relief28 g in 1 TUBECREAM281
41167-0029-1Cortizone 10 Ultra Soothing Itch Relief56 g in 1 TUBECREAM561
41167-0029-1Cortizone 10 Ultra Soothing Itch Relief1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41167-0029CORTIZONE 10 ULTRA SOOTHING ITCH RELIEF (HYDROCORTISONE) CREAM [CHATTEM, INC.]1Current NDC, 4 package rows20250309_8a9e2d32-a65f-4253-8041-4146f4e3b738.zip

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
41167-002941167-0029-0, 41167-0029-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 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
Cortizone 10 Ultra Soothing Itch ReliefHYDROCORTISONEChattem, Inc.8a9e2d32-a65f-4253-8041-4146f4e3b7382025-02-21WarningsExact identifier
ndc (package): 41167-0029-1
ndc (package): 41167-0029-0
ndc (product): 41167-0029
ndc11 (package): 41167002901
ndc11 (package): 41167002900
spl id: f4922ec3-0943-46d7-9c4d-a0eb103538ec
spl set id: 8a9e2d32-a65f-4253-8041-4146f4e3b738

Reported adverse events (FAERS/openFDA)#

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