CeraVe

Manufacturer: Valeant Pharmaceuticals North America LLC | Accupac, Inc
Effective date: 2015-02-20
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: legacy-cache
Hydrated at: 2026-08-02 01:32:45

Label at a glance#

ProductCeraVe Therapeutic Hand

Active ingredientDIMETHICONE

Label structure10 sections

Indications and uses

Helps prevent and temporarily protect chafed, chapped, cracked, dry skin.

Dosage and administration

Apply liberally as often as necessary.

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

Dimethicone 1% w/w

Purpose

OTC - PURPOSE SECTION

Protectant

Uses

INDICATIONS & USAGE SECTION

Helps prevent and temporarily protect chafed, chapped, cracked, dry skin.

Warnings

WARNINGS SECTION

For external use only.

When using this product avoid contact with eyes.

Rinse with water to remove.

Stop use and ask a doctor

Condition worsens
Symptoms last more than 7 days or clear up and occur again within a few days.

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.

Not to be applied over deep or puncture wounds, infections or lacerations.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply liberally as often as necessary.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Purified Water, Cyclomethicone and Aluminum/Magnesium Hydroxide Stearate, Polyglyceryl-4 Isostearate and Cetyl PEG/PPG-10/1 Dimethicone and Hexyl Laurate, Sodium Chloride, Niacinamide, Phenoxyethanol, Propylparaben, Ceramide 3, Ceramide 6-II, Ceramide 1, Phytosphingosine, Hyaluronic Acid, Cholesterol, Sodium Lauroyl Lactylate, Carbomer, Xanthan Gum.

Other Information

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun

Questions?

OTC - QUESTIONS SECTION

Toll-free number 800-321-4576

www.cerave.com

201248925CA Rev. 06/13

Distributed by:
Valeant Consumer Products,

A division of Valeant Pharmaceuticals

North America LLC

Bridgewater, NJ 08807 USA

VALEANT™

Consumer Products

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CeraVe^®

DEVELOPED WITH DERMATOLOGISTS

Therapeutic

Hand Cream

FOR NORMAL TO DRY SKIN

Helps repair, restore, and

protect skin from harmful

irritants

Non-irritating, water resistant

and fragrance free

Skin protectant

With ceramides, niacinamide,

and hyaluronic acid

Net WT. 3 OZ (85 g)

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0187-2489-25	2021-05-06	C162847	48780-1	9d75b9d0-5acd-f424-e053-dadaa90a57ce	Drug Facts
0187-2489-31	2021-05-06	C162847	48780-1	9d75b9d0-5acd-f424-e053-dadaa90a57ce	Drug Facts
0187-2489-25	2020-01-31	C162847	48780-1	9d75b9d0-5acd-f424-e053-dadaa90a57ce	Drug Facts
0187-2489-31	2020-01-31	C162847	48780-1	9d75b9d0-5acd-f424-e053-dadaa90a57ce	Drug Facts

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
DIMETHICONE	ACTIVE INGREDIENT	92RU3N3Y1O	2
DIMETHICONE	ACTIVE MOIETY	92RU3N3Y1O	2
ALUMINUM HYDROXIDE	INACTIVE INGREDIENT	5QB0T2IUN0	2
CERAMIDE 1	INACTIVE INGREDIENT	5THT33P7X7	2
CERAMIDE 3	INACTIVE INGREDIENT	4370DF050B	2
CERAMIDE 6 II	INACTIVE INGREDIENT	F1X8L2B00J	2
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5)	INACTIVE INGREDIENT	035JKJ76MT	2
CHOLESTEROL	INACTIVE INGREDIENT	97C5T2UQ7J	2
CYCLOMETHICONE	INACTIVE INGREDIENT	NMQ347994Z	2
HEXYL LAURATE	INACTIVE INGREDIENT	4CG9F9W01Q	2
HYALURONIC ACID	INACTIVE INGREDIENT	S270N0TRQY	2
MAGNESIUM HYDROXIDE	INACTIVE INGREDIENT	NBZ3QY004S	2
NIACINAMIDE	INACTIVE INGREDIENT	25X51I8RD4	2
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	2
PHYTOSPHINGOSINE	INACTIVE INGREDIENT	GIN46U9Q2Q	2
POLYGLYCERYL-4 ISOSTEARATE	INACTIVE INGREDIENT	820DPX33S7	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	2
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	2
SODIUM LAUROYL LACTYLATE	INACTIVE INGREDIENT	7243K85WFO	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	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 · 22 matching rows.

CeraVe Therapeutic Hand
dimethicone
WATER
CYCLOMETHICONE
STEARIC ACID
ALUMINUM HYDROXIDE
MAGNESIUM HYDROXIDE
POLYGLYCERYL-4 ISOSTEARATE
HEXYL LAURATE
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5)
SODIUM CHLORIDE
NIACINAMIDE
PHENOXYETHANOL
PROPYLPARABEN
CERAMIDE 3
CERAMIDE 6 II
CERAMIDE 1
PHYTOSPHINGOSINE
HYALURONIC ACID
CHOLESTEROL
SODIUM LAUROYL LACTYLATE
XANTHAN GUM

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0187-2489	0187-2489-25, 0187-2489-31

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
DIMETHICONE	92RU3N3Y1O	ACTIB
WATER	059QF0KO0R	IACT
CYCLOMETHICONE	NMQ347994Z	IACT
STEARIC ACID	4ELV7Z65AP	IACT
ALUMINUM HYDROXIDE	5QB0T2IUN0	IACT
MAGNESIUM HYDROXIDE	NBZ3QY004S	IACT
POLYGLYCERYL-4 ISOSTEARATE	820DPX33S7	IACT
HEXYL LAURATE	4CG9F9W01Q	IACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5)	035JKJ76MT	IACT
SODIUM CHLORIDE	451W47IQ8X	IACT
NIACINAMIDE	25X51I8RD4	IACT
PHENOXYETHANOL	HIE492ZZ3T	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
CERAMIDE 3	4370DF050B	IACT
CERAMIDE 6 II	F1X8L2B00J	IACT
CERAMIDE 1	5THT33P7X7	IACT
PHYTOSPHINGOSINE	GIN46U9Q2Q	IACT
HYALURONIC ACID	S270N0TRQY	IACT
CHOLESTEROL	97C5T2UQ7J	IACT
SODIUM LAUROYL LACTYLATE	7243K85WFO	IACT
XANTHAN GUM	TTV12P4NEE	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 5 · 292 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	GRANULE, FOR SUSPENSION / ORAL		162 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SUSPENSION / INTRALESIONAL		13 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	TABLET / ORAL		231 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	CREAM / VAGINAL		3 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	CREAM / VAGINAL		1088 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS		2922 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	CAPSULE / ORAL		6 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	GEL / VAGINAL	10 %w/w		Exact identifier — unii candidate 134 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, SOLUTION / INTRAVENOUS		5 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION, CONCENTRATE / INTRAMUSCULAR	0.86 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	CREAM / TOPICAL	0.4 %w/w		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	DROPS / NASAL	NA		Exact identifier — unii candidate 134 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	POWDER, FOR SOLUTION / ORAL		13 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, FILM COATED / ORAL		176 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	LOZENGE / ORAL		1264 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / RESPIRATORY (INHALATION)		43 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / SOFT TISSUE	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
ALUMINUM HYDROXIDE	ALUMINUM HYDROXIDE	5QB0T2IUN0	CAPSULE / ORAL	NA		Exact identifier — unii candidate 4 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	LOTION / TOPICAL	1 %w/w		Exact identifier — unii candidate 6 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET / SUBLINGUAL	9 mg		Exact identifier — unii candidate 26 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	CREAM / TOPICAL		6 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	TABLET, CHEWABLE / ORAL		20 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	TABLET, COATED / ORAL	54.7 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	FILM, SOLUBLE / ORAL		1 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
CYCLOMETHICONE	CYCLOMETHICONE	NMQ347994Z	SOLUTION / TOPICAL	11.57 %w/v		Exact identifier — unii candidate 5 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		120 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SHAMPOO / TOPICAL		150 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	AEROSOL / TOPICAL	1.05 %w/w		Exact identifier — unii candidate 6 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INFILTRATION		648 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / INTRAVESICAL		351 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	CREAM / TOPICAL		190 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / INFILTRATION		3535 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / TOPICAL	0.32 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	POWDER, FOR SUSPENSION / ORAL		8 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, FOR SOLUTION / INTRAPERITONEAL	226 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	TROCHE / ORAL		948 mg	Exact identifier — unii candidate 29 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
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	ENEMA / RECTAL	0.02 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / OPHTHALMIC		13 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / ORAL		1126 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	TABLET, CHEWABLE / ORAL	0.14 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, FOR SUSPENSION / SUBCUTANEOUS	NA		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR		360 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	AEROSOL, FOAM / TOPICAL		72 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
NIACINAMIDE	NIACINAMIDE	25X51I8RD4	CREAM / TOPICAL	NA		Exact identifier — unii candidate 4 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, FOR SOLUTION / INTRA-ARTERIAL	1.35 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / INTRAVENOUS		2916 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	LIQUID / SUBCUTANEOUS	0.7 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION/ DROPS / OPHTHALMIC	0.01 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	JELLY / NASAL	140 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / RECTAL	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / INTRAMUSCULAR		90 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, COATED / ORAL	42.4 mg		Exact identifier — unii candidate 26 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, DELAYED RELEASE / ORAL		80 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / AURICULAR (OTIC)	0.9 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / EPIDURAL		3535 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
NIACINAMIDE	NIACINAMIDE	25X51I8RD4	GEL / TOPICAL		25 mg	Exact identifier — unii candidate 4 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / ENDOTRACHEAL		68 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	POWDER / TOPICAL	NA		Exact identifier — unii candidate 134 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SOLUTION / OPHTHALMIC	0.6 %w/v		Exact identifier — unii candidate 29 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
6efa49e9-9f0a-4045-925e-c6c4880896a9			271d346d-be43-49b8-8cdd-ad0d0139b832	2021-05-06	Warnings	Exact identifier spl set id: 271d346d-be43-49b8-8cdd-ad0d0139b832

Reported adverse events (FAERS/openFDA)#

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