CeraVe

Manufacturer: Valeant Pharmaceuticals North America LLC | Accupac, Inc
Effective date: 2015-02-10
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: legacy-cache
Hydrated at: 2026-08-02 01:33:00

Label at a glance#

ProductCeraVe Anti-Itch

Active ingredientHYDROCORTISONE

Label structure11 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.

Contacts and useful links#

PhoneLabel contact800-321-4576

Websitewww.cerave.com

www.CeraVe.com

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 use for the treatment of diaper rash, consult a doctor.
When using this product avoid contact with eyes.
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. 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: do not use, ask a doctor.

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, cetearyl alcohol, ceteareth-20, glycerin, isopropyl myristate, cyclopentasiloxane, benzyl alcohol, cetyl palmitate, isostearyl neopentanoate, citric acid, potassium lactate, dimethicone/vinyltrimethylsiloxysilicate crosspolymer, dimethyl MEA, PEG-40 stearate,

methylparaben, aloe barbadensis (aloe vera) leaf juice, niacinamide, avena sativa (oat) kernel extract, sodium lauroyl lactylate, chrysanthemum parthenium (feverfew) extract, hyaluronic acid, sodium hydroxide, ceramide 3, ceramide 6 II, phytosphingosine, cholesterol, xanthan gum, carbomer, ceramide 1

Other information

OTHER SAFETY INFORMATION

store at 20° to 25°C (68° to 77°F)

Questions

OTC - QUESTIONS SECTION

Toll-free number 800-321-4576

www.CeraVe.com

Distributed by:

Valeant Consumer Products,

a Division of Valeant

Pharmaceuticals

North America LLC,

Bridgewater, NJ 08807

9389500 Rev. 04/14

VALEANT™

Consumer Products

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW

CeraVe®

DEVELOPED WITH DERMATOLOGISTS

Hydrocortisone

Anti-Itch Cream

FOR RASHES DUE TO ECZEMA

Relieves itch flare-ups due

to extra dry skin and eczema

Longest lasting hydrocortisone

cream without a prescription

Helps repair & restore

protective skin barrier

With essential ceramides

Maximum strength

Fragrance free

Net WT. 1 OZ (28 g)

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW

CeraVe®

DEVELOPED WITH DERMATOLOGISTS

Hydrocortisone

Anti-Itch Cream

For rashes due

to eczema

Net WT. 1 OZ (28 g)

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0187-2486-05	2021-05-07	C162847	48780-1	9d75b9d0-dccf-f424-e053-dadaa90a57ce	Drug Facts
0187-2486-10	2021-05-07	C162847	48780-1	9d75b9d0-dccf-f424-e053-dadaa90a57ce	Drug Facts
0187-2486-05	2020-01-31	C162847	48780-1	9d75b9d0-dccf-f424-e053-dadaa90a57ce	Drug Facts
0187-2486-10	2020-01-31	C162847	48780-1	9d75b9d0-dccf-f424-e053-dadaa90a57ce	Drug Facts

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
HYDROCORTISONE	ACTIVE INGREDIENT	WI4X0X7BPJ	2
HYDROCORTISONE	ACTIVE MOIETY	WI4X0X7BPJ	2
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	2
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	2
CERAMIDE 1	INACTIVE INGREDIENT	5THT33P7X7	2
CERAMIDE 3	INACTIVE INGREDIENT	4370DF050B	2
CERAMIDE 6 II	INACTIVE INGREDIENT	F1X8L2B00J	2
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	2
CETYL PALMITATE	INACTIVE INGREDIENT	5ZA2S6B08X	2
CHOLESTEROL	INACTIVE INGREDIENT	97C5T2UQ7J	2
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	2
CYCLOMETHICONE 5	INACTIVE INGREDIENT	0THT5PCI0R	2
DEANOL	INACTIVE INGREDIENT	2N6K9DRA24	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	2
ISOPROPYL MYRISTATE	INACTIVE INGREDIENT	0RE8K4LNJS	2
ISOSTEARYL NEOPENTANOATE	INACTIVE INGREDIENT	411THY156Q	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	2
NIACINAMIDE	INACTIVE INGREDIENT	25X51I8RD4	2
OAT	INACTIVE INGREDIENT	Z6J799EAJK	2
PEG-40 STEARATE	INACTIVE INGREDIENT	ECU18C66Q7	2
PHYTOSPHINGOSINE	INACTIVE INGREDIENT	GIN46U9Q2Q	2
POLYOXYL 20 CETOSTEARYL ETHER	INACTIVE INGREDIENT	YRC528SWUY	2
POTASSIUM LACTATE	INACTIVE INGREDIENT	87V1KMK4QV	2
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	2
SODIUM LAUROYL LACTYLATE	INACTIVE INGREDIENT	7243K85WFO	2
TANACETUM PARTHENIUM	INACTIVE INGREDIENT	6GE7Z0761K	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	2
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	2

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

CeraVe Anti-Itch
Hydrocortisone
WATER
CETOSTEARYL ALCOHOL
POLYOXYL 20 CETOSTEARYL ETHER
GLYCERIN
ISOPROPYL MYRISTATE
CYCLOMETHICONE 5
BENZYL ALCOHOL
CETYL PALMITATE
ISOSTEARYL NEOPENTANOATE
CITRIC ACID MONOHYDRATE
POTASSIUM LACTATE
DEANOL
PEG-40 STEARATE
METHYLPARABEN
ALOE VERA LEAF
NIACINAMIDE
OAT
SODIUM LAUROYL LACTYLATE
TANACETUM PARTHENIUM
SODIUM HYDROXIDE
CERAMIDE 3
CERAMIDE 6 II
PHYTOSPHINGOSINE
CHOLESTEROL
XANTHAN GUM
CERAMIDE 1

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0187-2486	0187-2486-10, 0187-2486-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
HYDROCORTISONE	WI4X0X7BPJ	ACTIB
WATER	059QF0KO0R	IACT
CETOSTEARYL ALCOHOL	2DMT128M1S	IACT
POLYOXYL 20 CETOSTEARYL ETHER	YRC528SWUY	IACT
GLYCERIN	PDC6A3C0OX	IACT
ISOPROPYL MYRISTATE	0RE8K4LNJS	IACT
CYCLOMETHICONE 5	0THT5PCI0R	IACT
BENZYL ALCOHOL	LKG8494WBH	IACT
CETYL PALMITATE	5ZA2S6B08X	IACT
ISOSTEARYL NEOPENTANOATE	411THY156Q	IACT
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT
POTASSIUM LACTATE	87V1KMK4QV	IACT
DEANOL	2N6K9DRA24	IACT
PEG-40 STEARATE	ECU18C66Q7	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
ALOE VERA LEAF	ZY81Z83H0X	IACT
NIACINAMIDE	25X51I8RD4	IACT
OAT	Z6J799EAJK	IACT
SODIUM LAUROYL LACTYLATE	7243K85WFO	IACT
TANACETUM PARTHENIUM	6GE7Z0761K	IACT
SODIUM HYDROXIDE	55X04QC32I	IACT
CERAMIDE 3	4370DF050B	IACT
CERAMIDE 6 II	F1X8L2B00J	IACT
PHYTOSPHINGOSINE	GIN46U9Q2Q	IACT
CHOLESTEROL	97C5T2UQ7J	IACT
XANTHAN GUM	TTV12P4NEE	IACT
CERAMIDE 1	5THT33P7X7	IACT

Source Document#

Source XML

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 10 · 550 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SOLUTION / PARENTERAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	DROPS / OPHTHALMIC	NA		Exact identifier — unii candidate 174 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	SOLUTION / INTRAVENOUS		242 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	OINTMENT / TOPICAL	35 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		6 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, SOLUTION, CONCENTRATE / INTRAOCULAR		1 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		36 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	144 mg		Exact identifier — unii candidate 50 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SHAMPOO, SUSPENSION / TOPICAL	0.25 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTERSTITIAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SUSPENSION / AURICULAR (OTIC)	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SUSPENSION, EXTENDED RELEASE / INTRASYNOVIAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INTRAVENOUS	2068 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INTRABURSAL	ADJ PH		Exact identifier — unii candidate 88 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, FOR SOLUTION / INTRATUMOR	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SUSPENSION / OPHTHALMIC		2 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	TABLET, COATED / ORAL	0.8 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	LOTION / TOPICAL		50 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SOLUTION / ORAL		84 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION / INTRAVENOUS		33750 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / INTRAVENOUS	0.13 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRAVASCULAR	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
POLYOXYL 20 CETOSTEARYL ETHER	POLYOXYL 20 CETOSTEARYL ETHER	YRC528SWUY	SPRAY / TOPICAL	2.42 %w/w		Exact identifier — unii candidate 7 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	TABLET / ORAL	1.06 mg		Exact identifier — unii candidate 50 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	GRANULE, FOR SUSPENSION / ORAL		80 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / EPIDURAL	0.02 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
POLYOXYL 20 CETOSTEARYL ETHER	POLYOXYL 20 CETOSTEARYL ETHER	YRC528SWUY	AEROSOL / TOPICAL	5.5 %w/w		Exact identifier — unii candidate 7 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	TABLET, EXTENDED RELEASE / ORAL		528 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
NIACINAMIDE	NIACINAMIDE	25X51I8RD4	CREAM / TOPICAL	NA		Exact identifier — unii candidate 4 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / RECTAL	NA		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	EMULSION / OPHTHALMIC	0.02 %w/v		Exact identifier — unii candidate 174 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	AEROSOL, FOAM / TOPICAL	0.27 %w/w		Exact identifier — unii candidate 29 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION, SUSPENSION / SOFT TISSUE		40 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SUSPENSION / ORAL	400 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SYSTEM / IONTOPHORESIS	0.2 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	EMULSION / ORAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	TABLET / ORAL	1.8 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRAPERITONEAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	CAPSULE, DELAYED RELEASE / ORAL	0.25 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
CHOLESTEROL	CHOLESTEROL	97C5T2UQ7J	CREAM / TOPICAL	1 %w/w		Exact identifier — unii candidate 10 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SOLUTION / OPHTHALMIC	0.6 %w/v		Exact identifier — unii candidate 29 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / PARENTERAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	FILM, SOLUBLE / ORAL		1 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	JELLY / TOPICAL		420 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRASPINAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SOLUTION / INTRA-ARTICULAR	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
CHOLESTEROL	CHOLESTEROL	97C5T2UQ7J	LOTION / TOPICAL		20 mg	Exact identifier — unii candidate 10 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	GEL, METERED / TRANSDERMAL		50 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC	0.6 %w/w		Exact identifier — unii candidate 29 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION / INTRA-ARTICULAR	1 %w/v		Exact identifier — unii candidate 50 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / EPIDURAL	1 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	POWDER, FOR SOLUTION / ORAL		126 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
POLYOXYL 20 CETOSTEARYL ETHER	POLYOXYL 20 CETOSTEARYL ETHER	YRC528SWUY	AEROSOL, FOAM / TOPICAL		374 mg	Exact identifier — unii candidate 7 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	GEL / TOPICAL		1 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, SOLUTION / INTRAVENOUS		396 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / DENTAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / TOPICAL		39 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	LOTION / TOPICAL		21 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	CREAM / TOPICAL		1428 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SOLUTION / INTRACAUDAL	ADJ PH		Exact identifier — unii candidate 174 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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
adb844b7-c0c4-4b99-88ed-7c44695d1791			b17183c5-dea5-497f-bc8c-b667ab6f1e1d	2015-02-10	Warnings	Exact identifier spl set id: b17183c5-dea5-497f-bc8c-b667ab6f1e1d

Reported adverse events (FAERS/openFDA)#

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