CeraVe Developed with Dermatologists Anti Itch

Manufacturer
L'Oreal USA Products Inc. | Accupac, Inc
Effective date
2023-12-31
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:06:15

Label at a glance#

ProductCeraVe Developed with Dermatologists Anti Itch
Active ingredientHYDROCORTISONE
Label structure13 sections

Indications and uses

temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to: eczema, soaps, detergents, cosmetics, seborrheic dermatitis, psoriasis 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: do not use, 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 itching associated with minor skin irritations, inflammation, and rashes due to: eczema, soaps, detergents, cosmetics, seborrheic dermatitis, psoriasis
  • 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 uses

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 the eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, cetearyl alcohol, glycerin, ceteareth-20, isopropyl myristate, cyclopentasiloxane, benzyl alcohol, isostearyl neopentanoate, cetyl palmitate, PEG-40 stearate,. potassium lactate, ceramide NP, ceramide AP, potassium sorbate,. ceramide EOP, carbomer, niacinamide, dimethicone/vinyltrimethylsiloxysilicate crosspolymer, dimethyl MEA, aloe barbadensis leaf juice, methylparaben, sodium lauroyl lactylate, sodium hyaluronate, sodium benzoate, cholesterol, avena sativa (oat) kernel extract, phenoxyethanol, citric acid, phytosphingosine, xanthan gum, maltodextrin, chrysanthemum parthenium (feverfew) extract, ethylhexylglycerin

Other information

OTHER SAFETY INFORMATION

store at 20° to 25°C (68° to 77°F)

Questions

OTC - QUESTIONS SECTION

Toll-free number 1-888-768-2915

www.CeraVe.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of a cartonimage of a carton

image of a carton
image of a carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
106258hydrocortisone 1 % Topical CreamPSN6
106258hydrocortisone 10 MG/ML Topical CreamSCD6
106258hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical CreamSY6
106258hydrocortisone 1 % Topical CreamSY6
106258hydrocortisone 1 GM per 100 GM Topical CreamSY6

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
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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
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36fdc54c-bbeb-981e-8a53-4d768e283892Product name120140508
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705740e1-dee5-2610-c5a3-4c59cd9d62afProduct name120140508
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a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
abaf203f-619e-f265-559f-8c81af5cb1c2Product name120140508
acc4d8bb-0e29-e9f8-65f8-31e94184a9c0Product name120140508
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fe21f3fd-a378-0654-1972-db3c3b64470eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49967-108-01CeraVe Developed with Dermatologists Anti Itch28 g in 1 TUBECREAM286
49967-108-01CeraVe Developed with Dermatologists Anti Itch1 in 1 CARTONCREAM16
49967-108-02CeraVe Developed with Dermatologists Anti Itch14 g in 1 TUBECREAM146

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49967-108CERAVE DEVELOPED WITH DERMATOLOGISTS ANTI ITCH (HYDROCORTISONE) CREAM [L'OREAL USA PRODUCTS INC.]6Current NDC, Legacy NDC, 3 package rows20240101_8d65e945-2557-486f-9279-ecbaa08f31c4.zip

Products#

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

DailyMed product names page 1 of 1 · 33 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49967-10849967-108-01, 49967-108-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 32 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
CeraVe Developed with Dermatologists Anti ItchHYDROCORTISONEL'Oreal USA Products Inc.8d65e945-2557-486f-9279-ecbaa08f31c42023-12-31WarningsExact identifier
ndc (package): 49967-108-02
ndc (package): 49967-108-01
ndc (product): 49967-108
ndc11 (package): 49967010801
ndc11 (package): 49967010802
spl id: fdc43cb3-3b00-4682-b30a-19df3a9dc5c7
spl set id: 8d65e945-2557-486f-9279-ecbaa08f31c4

Reported adverse events (FAERS/openFDA)#

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