FDA.reportPublic FDA data

Cortizone 10 Intensive Healing for Eczema

Manufacturer
Chattem, Inc.
Effective date
2026-01-14
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
monthly-update
Hydrated at
2026-06-03 17:52:17

Label at a glance#

ProductCortizone 10 Intensive Healing for Eczema
Active ingredientHYDROCORTISONE
Label structure8 sections

Indications and uses

temporarily relieves the itching and discomfort associated with minor skin irritations, rashes, and inflammation, and due to eczema 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 Ingredient:

OTC - ACTIVE INGREDIENT SECTION

Hydrocortisone 1%

Purpose

OTC - PURPOSE SECTION

Anti-itch

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves the itching and discomfort associated with minor skin irritations, rashes, and inflammation, and due to eczema
  • 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. 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.

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

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

  • contents filled by weight, not volume

Inactive Ingredients

INACTIVE INGREDIENT SECTION

aloe barbadensis leaf juice, avena sativa (oat) kernel extract, bisabolol, boswellia serata gum, butyrospermum parkii (shea) butter extract, cetyl alcohol, dextrin, dimethicone, dipropylene glycol, disodium EDTA, glycerin, glyceryl stearate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, isohexadecane, magnesium ascorbyl phosphate, maltodextrin, methyl gluceth-20, methylparaben, petrolatum, phenoxyethanol, polysorbate 60, propylparaben, retinyl palmitate, sodium citrate, tocopheryl acetate, water, singiber officinale (ginger) root extract (283-035) 

*Clinically proven to moisturize for 24 hours

**Refers to the ingredient hydrocortisone

†Contains 7 healing moisturizers and vitamins A, C & E

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW!

Fast, Lasting

Itch Relief

MAXIMUM STRENGTH

Cortizone-10®

INTENSIVE HEALING

LOTION†

ECZEMA

And Itchy, Dry Skin

Dermatologist

Recommended

  • 7 intensive moisturizers
  • Clinical strength*

 With

Restora TM 

Botanical &

Vitamin Complex

1% Hydrocortisone Anti-Itch Lotion

DOCTORS

#1 ITCH MEDICINE

RECOMMEND

Net wt 3.5 oz (99g)

Principal Display Panel NEW! Fast, Lasting Itch Relief MAXIMUM STRENGTH Cortizone-10® INTENSIVE HEALING LOTION† ECZEMA And Itchy, Dry Skin Dermatologist Recommended  7 intensiv...Principal Display Panel NEW! Fast, Lasting Itch Relief MAXIMUM STRENGTH Cortizone-10® INTENSIVE HEALING LOTION† ECZEMA And Itchy, Dry Skin Dermatologist Recommended  7 intensiv...

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039279Cortizone-10 1 % Topical LotionPSN5
103403hydrocortisone 1 % Topical LotionPSN5
1039279hydrocortisone 10 MG/ML Topical Lotion [Cortizone]SBD5
103403hydrocortisone 10 MG/ML Topical LotionSCD5
1039279Cortizone 1 % Topical LotionSY5
1039279Cortizone 10 MG/ML Topical LotionSY5
103403hydrocortisone 1 % Topical LotionSY5

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130041167033104GTIN-13: 0041167033104
EAN-13: 0041167033104
GTIN-12: 041167033104
UPC-A: 041167033104
GTIN storage (14 digits): 00041167033104		cortizone-10-intensive-healing-for-eczema-01.jpg

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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
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
41167-0331-0Cortizone 10 Intensive Healing for Eczema99 g in 1 TUBELOTION995
41167-0331-0Cortizone 10 Intensive Healing for Eczema1 in 1 CARTONLOTION15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
HYDROCORTISONEACTIVE INGREDIENTWI4X0X7BPJ1
HYDROCORTISONEACTIVE MOIETYWI4X0X7BPJ1
.ALPHA.-TOCOPHEROL ACETATE, D-INACTIVE INGREDIENTA7E6112E4N1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCN1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O1
DIPROPYLENE GLYCOLINACTIVE INGREDIENTE107L85C401
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE41
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2D1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9U1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T1
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4M1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULR1
VITAMIN A PALMITATEINACTIVE INGREDIENT1D1K0N0VVC1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
41167-033141167-0331-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYDROCORTISONEWI4X0X7BPJACTIB
ALOE VERA LEAFZY81Z83H0XIACT
CETYL ALCOHOL936JST6JCNIACT
DIMETHICONE92RU3N3Y1OIACT
DIPROPYLENE GLYCOLE107L85C40IACT
EDETATE DISODIUM7FLD91C86KIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
MALTODEXTRIN7CVR7L4A2DIACT
METHYLPARABENA2I8C7HI9TIACT
PETROLATUM4T6H12BN9UIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYSORBATE 60CAL22UVI4MIACT
PROPYLPARABENZ8IX2SC1OHIACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
SODIUM CITRATE1Q73Q2JULRIACT
.ALPHA.-TOCOPHEROL ACETATE, D-A7E6112E4NIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
42023-11-06full-release2026-06-01 00:03:22

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 · 54 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DPOWDER, FOR SUSPENSION / ORAL8000 mgExact identifier — unii candidate
30 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DPASTE / ORAL1050 mgExact identifier — unii candidate
30 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET, ORALLY DISINTEGRATING / ORAL12 mgExact identifier — unii candidate
30 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNLOTION / TOPICAL1140 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET, COATED / ORAL5.6 mgExact identifier — unii candidate
30 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DPASTE / ORAL1050 mgExact identifier — unii candidate
30 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHLOTION / TOPICAL140 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET, CHEWABLE / ORAL292 mgExact identifier — unii candidate
30 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DSOLUTION / ORAL1451 mgExact identifier — unii candidate
30 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLOTION / TOPICAL3990 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET / ORAL320 mgExact identifier — unii candidate
30 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET, ORALLY DISINTEGRATING / ORAL12 mgExact identifier — unii candidate
30 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DSUSPENSION / ORAL6040 mgExact identifier — unii candidate
30 equally ranked IID candidates
DIPROPYLENE GLYCOLDIPROPYLENE GLYCOLE107L85C40FILM, EXTENDED RELEASE / BUCCAL30 mgExact identifier — unii candidate
6 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DCAPSULE / ORAL200 mgExact identifier — unii candidate
30 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MLOTION / TOPICAL5 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DPOWDER, FOR SUSPENSION / ORAL8000 mgExact identifier — unii candidate
30 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DFILM, SOLUBLE / ORAL19 mgExact identifier — unii candidate
30 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNLOTION / TOPICAL1140 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4LOTION / TOPICAL177 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9ULOTION / TOPICAL25 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET, EFFERVESCENT / ORAL14404 mgExact identifier — unii candidate
30 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TLOTION / TOPICAL351 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET, FILM COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
30 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DSOLUTION / ORAL1451 mgExact identifier — unii candidate
30 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TLOTION / TOPICAL351 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DSUSPENSION / ORAL6040 mgExact identifier — unii candidate
30 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET, EXTENDED RELEASE / ORAL3239 mgExact identifier — unii candidate
30 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4LOTION / TOPICAL177 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET, EFFERVESCENT / ORAL14404 mgExact identifier — unii candidate
30 equally ranked IID candidates
DIPROPYLENE GLYCOLDIPROPYLENE GLYCOLE107L85C40FILM, EXTENDED RELEASE / TRANSDERMAL296 mgExact identifier — unii candidate
6 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KLOTION / TOPICAL22 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHLOTION / TOPICAL140 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET, COATED / ORAL5.6 mgExact identifier — unii candidate
30 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TLOTION / TOPICAL1 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MLOTION / TOPICAL5 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KLOTION / TOPICAL22 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9ULOTION / TOPICAL25 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
DIPROPYLENE GLYCOLDIPROPYLENE GLYCOLE107L85C40SYSTEM / TRANSDERMAL6 mgExact identifier — unii candidate
6 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLOTION / TOPICAL3990 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DLOZENGE / ORAL175 mgExact identifier — unii candidate
30 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET / ORAL320 mgExact identifier — unii candidate
30 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TLOTION / TOPICAL1 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET, FILM COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
30 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DGRANULE, FOR SUSPENSION / ORAL952 mgExact identifier — unii candidate
30 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DLOZENGE / ORAL175 mgExact identifier — unii candidate
30 equally ranked IID candidates
DIPROPYLENE GLYCOLDIPROPYLENE GLYCOLE107L85C40FILM, EXTENDED RELEASE / TRANSDERMAL296 mgExact identifier — unii candidate
6 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET, EXTENDED RELEASE / ORAL3239 mgExact identifier — unii candidate
30 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DFILM, SOLUBLE / ORAL19 mgExact identifier — unii candidate
30 equally ranked IID candidates
DIPROPYLENE GLYCOLDIPROPYLENE GLYCOLE107L85C40SYSTEM / TRANSDERMAL6 mgExact identifier — unii candidate
6 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET, CHEWABLE / ORAL292 mgExact identifier — unii candidate
30 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DGRANULE, FOR SUSPENSION / ORAL952 mgExact identifier — unii candidate
30 equally ranked IID candidates
DIPROPYLENE GLYCOLDIPROPYLENE GLYCOLE107L85C40FILM, EXTENDED RELEASE / BUCCAL30 mgExact identifier — unii candidate
6 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DCAPSULE / ORAL200 mgExact identifier — unii candidate
30 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
Cortizone 10 Intensive Healing for EczemaHYDROCORTISONEChattem, Inc.31dc0f1f-ddd8-41dc-b669-b24655634d552026-01-14WarningsExact identifier
ndc (package): 41167-0331-0
ndc (product): 41167-0331
ndc11 (package): 41167033100
spl id: d4774d0b-59ad-4ca7-9af8-3754e3dbe6bd
spl set id: 31dc0f1f-ddd8-41dc-b669-b24655634d55

Reported adverse events (FAERS/openFDA)#

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