FDA.reportPublic FDA data

Aveeno 1% Hydrocortisone ANTI-ITCH Cream

Manufacturer
Kenvue Brands LLC
Effective date
2024-11-05
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 00:34:18

Label at a glance#

ProductAveeno Hydrocortisone ANTI-ITCH
Active ingredientHYDROCORTISONE
Label structure12 sections

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; ask a doctor.

Storage and handling

Protect from Excessive Heat (40°c/104°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydrocortisone 1%

Purpose

OTC - PURPOSE SECTION

Anti-Itch

Use

INDICATIONS & USAGE SECTION

For the temporary relief of itching associated with minor skin irritations and rashes due to:

  • eczema
  • insect bites
  • poison ivy, oak or sumac
  • soaps and detergents
  • cosmetics
  • jewelry
  • seborrheic dermatitis
  • psoriasis
  • Other uses of this product should be only under the advice and supervision of doctor

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

  • in or near the eyes
  • for diaper rash; ask a doctor

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you are using any other hydrocortisone product

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens or if symptoms persists for more than 7 days
  • symptoms last more than 7 days or clear up and occur again within a few days

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 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, do not use; ask a doctor.

Sunburn Alert

SPL UNCLASSIFIED SECTION

This product contains an alpha hydroxy acid (AHA) that may increase your skin's sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen, wear protective clothing, and limit sun exposure while using this product and for a week afterwards.

Other information

STORAGE AND HANDLING SECTION

Protect from Excessive Heat (40°c/104°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Cetearyl Alcohol, Glycerin, Isopropyl Myristate, Cetereath-20, Cyclopentasiloxane, Avena Sativa (Oat) Kernel flour, Cetyl Palmitate, Isostearyl Neopentanoate, Benzyl Alcohol, Dimethicone/Vinyltrimethylsiloxysilicate Crosspolymer, Potassium Lactate, PEG-40 Stearate, Methylparaben, Citric Acid, Tocopheryl Acetate, Aloe Barbadensis Leaf Extract, Avena Sativa (Oat) Kernel Oil, Avena Sativa (Oat) Kernel Extract, Sodium Hydroxide

Questions?

OTC - QUESTIONS SECTION

866-428-3366; Outside US, dial collect 215-273-8755 www.aveeno.com

SPL UNCLASSIFIED SECTION

Distributed by:
JOHNSON & JOHNSON CONSUMER INC.
Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Aveeno®

1% Hydrocortisone

ANTI-ITCH CREAM

Effectively relieves itch from:

Eczema ● Psoriasis

Poison Ivy ● Oak ● Sumac

Insect Bites ● Detergents ● Soaps

Maximum Strength Formula

Specially formulated for longer-lasting relief

With Triple Oat, Aloe, & Vitamin E

DERMATOLOGIST RECOMMENDED BRAND

TRIPLE OAT

net wt. 1 oz (28 g)

AveenoAveeno

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
106258hydrocortisone 1 % Topical CreamPSN8
106258hydrocortisone 10 MG/ML Topical CreamSCD8
106258hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical CreamSY8
106258hydrocortisone 1 % Topical CreamSY8
106258hydrocortisone 1 GM per 100 GM Topical CreamSY8

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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct 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
69968-0511-1Aveeno Hydrocortisone ANTI-ITCH28 g in 1 TUBECREAM288
69968-0511-1Aveeno Hydrocortisone ANTI-ITCH1 in 1 CARTONCREAM18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0511AVEENO HYDROCORTISONE ANTI-ITCH (HYDROCORTISONE) CREAM [KENVUE BRANDS LLC]8Current NDC, Legacy NDC, 2 package rows20241107_233de4d7-e533-40cd-a5ed-e8b09abc626e.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69968-051169968-0511-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
GLYCERINPDC6A3C0OXIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
CYCLOMETHICONE 50THT5PCI0RIACT
OATMEAL8PI54V663YIACT
CETYL PALMITATE5ZA2S6B08XIACT
ISOSTEARYL NEOPENTANOATE411THY156QIACT
BENZYL ALCOHOLLKG8494WBHIACT
POTASSIUM LACTATE87V1KMK4QVIACT
METHYLPARABENA2I8C7HI9TIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
OAT KERNEL OIL3UVP41R77RIACT
OATZ6J799EAJKIACT
ALOE VERA LEAFZY81Z83H0XIACT
SODIUM HYDROXIDE55X04QC32IIACT
PEG-40 STEARATEECU18C66Q7IACT
HYDROCORTISONEWI4X0X7BPJACTIB

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
Aveeno Hydrocortisone ANTI-ITCHHYDROCORTISONEKenvue Brands LLC233de4d7-e533-40cd-a5ed-e8b09abc626e2024-11-05WarningsExact identifier
ndc (package): 69968-0511-1
ndc (product): 69968-0511
ndc11 (package): 69968051101
spl id: 22789a3a-e96e-7763-e063-6394a90ad040
spl set id: 233de4d7-e533-40cd-a5ed-e8b09abc626e