FDA.reportPublic FDA data

CeraVe

Manufacturer
Valeant Pharmaceuticals North America LLC | Product Quest Mfg, LLC | Accupac, Inc.
Effective date
2016-01-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 01:29:20

Label at a glance#

ProductCeraVe Healing
Active ingredientPETROLATUM
Label structure9 sections

Indications and uses

• temporarily protects and helps relieve chafed, chapped or cracked skin • temporarily protects minor: cuts, scrapes, burns • helps protect from the drying effects of wind and cold weather

Dosage and administration

• apply as needed

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Petrolatum 46.5%

Purpose

OTC - PURPOSE SECTION

Skin protectant (ointment)

Uses

INDICATIONS & USAGE SECTION

  • temporarily protects and helps relieve chafed, chapped or cracked skin
  • temporarily protects minor: cuts, scrapes, burns
  • helps protect from the drying effects of wind and cold weather

Warnings

WARNINGS SECTION

For external use only

When using this product

  • do not get into eyes

Stop use and ask a doctor if

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

Do not use on

  • deep or puncture wounds
  • animal bites
  • serious burns

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 immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply as needed

Inactive ingredients

INACTIVE INGREDIENT SECTION

mineral oil, paraffin, ozokerite, dimethicone, hyaluronic acid, sodium hydroxide, ceramide 1, ceramide 3,

ceramide 6-II, tocopheryl acetate, phytosphingosine, cholesterol, sodium lauroyl lactylate, carbomer, panthenol, water, L-proline, xanthan gum

Questions?

OTC - QUESTIONS SECTION

Toll-Free Number 800-321-4576

www.cerave.com

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW

CeraVe

DEVELOPED WITH DERMATOLOGISTS

Healing

Ointment

Protects and soothes dry,

cracked & chafed skin

NON - GREASY FEEL

[icon/seal] National Eczema Association

Skin Protectant

With ceramides

Net Wt. 12 OZ (340 g)

CeraVe Healing Ointment 12 OZ Jar Front and Back Label
CeraVe Healing Ointment 12 OZ Jar Front and Back Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0187-1950-032021-05-20C16284748780-19d75b9cf-fc9b-f424-e053-dadaa90a57ceDrug Facts
0187-1950-052021-05-20C16284748780-19d75b9cf-fc9b-f424-e053-dadaa90a57ceDrug Facts
0187-1950-122021-05-20C16284748780-19d75b9cf-fc9b-f424-e053-dadaa90a57ceDrug Facts
0187-1950-352021-05-20C16284748780-19d75b9cf-fc9b-f424-e053-dadaa90a57ceDrug Facts
0187-1950-402021-05-20C16284748780-19d75b9cf-fc9b-f424-e053-dadaa90a57ceDrug Facts
0187-1950-992021-05-20C16284748780-19d75b9cf-fc9b-f424-e053-dadaa90a57ceDrug Facts
0187-1950-032020-01-31C16284748780-19d75b9cf-fc9b-f424-e053-dadaa90a57ceDrug Facts
0187-1950-052020-01-31C16284748780-19d75b9cf-fc9b-f424-e053-dadaa90a57ceDrug Facts
0187-1950-122020-01-31C16284748780-19d75b9cf-fc9b-f424-e053-dadaa90a57ceDrug Facts
0187-1950-352020-01-31C16284748780-19d75b9cf-fc9b-f424-e053-dadaa90a57ceDrug Facts
0187-1950-402020-01-31C16284748780-19d75b9cf-fc9b-f424-e053-dadaa90a57ceDrug Facts
0187-1950-992020-01-31C16284748780-19d75b9cf-fc9b-f424-e053-dadaa90a57ceDrug Facts

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0187-19500187-1950-12, 0187-1950-03, 0187-1950-05, 0187-1950-99, 0187-1950-35, 0187-1950-40

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
PETROLATUM4T6H12BN9UACTIB
MINERAL OILT5L8T28FGPIACT
PARAFFINI9O0E3H2ZEIACT
CERESINQ1LS2UJO3AIACT
DIMETHICONE92RU3N3Y1OIACT
HYALURONIC ACIDS270N0TRQYIACT
SODIUM HYDROXIDE55X04QC32IIACT
CERAMIDE 15THT33P7X7IACT
CERAMIDE 34370DF050BIACT
CERAMIDE 6 IIF1X8L2B00JIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
PHYTOSPHINGOSINEGIN46U9Q2QIACT
CHOLESTEROL97C5T2UQ7JIACT
SODIUM LAUROYL LACTYLATE7243K85WFOIACT
CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)F68VH75CJCIACT
PANTHENOLWV9CM0O67ZIACT
WATER059QF0KO0RIACT
LAUROYL PROLINEHDI505B669IACT
XANTHAN GUMTTV12P4NEEIACT

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
3f25fcb9-fc04-4d2e-84dc-2a9303e72483323c4a33-a824-4297-b4df-b6ab33e24eb02016-01-07WarningsExact identifier
spl set id: 323c4a33-a824-4297-b4df-b6ab33e24eb0

Reported adverse events (FAERS/openFDA)#

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