FDA.reportPublic FDA data

CeraVe Developed with Dermatologists Healing

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 00:06:12

Label at a glance#

ProductCeraVe Developed with Dermatologists Healing
Active ingredientPETROLATUM
Label structure15 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 ingredient

OTC - ACTIVE INGREDIENT SECTION

Petrolatum 46.5%

Purpose

OTC - PURPOSE SECTION

Skin protectant

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

Do not use on

OTC - DO NOT USE SECTION

  • deep or puncture wounds
  • animal bites
  • serious burns

When using this product

OTC - WHEN USING SECTION

do not get into eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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 immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

apply as needed

Inactive ingredients

INACTIVE INGREDIENT SECTION

mineral oil, paraffin, ozokerite, dimethicone, ceramide NP, ceramide AP, ceramide EOP, carbomer, water, sodium lauroyl lactylate, proline, cholesterol, phenoxyethanol, tocopheryl acetate, tocopherol, hydrolyzed hyaluronic acid, panthenol, pantolactone, phytosphingosine, xanthan gum, ethylhexylglycerin

Questions?

OTC - QUESTIONS SECTION

Toll-Free Number 1-888-768-2915

www.cerave.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of a blister cardimage of a blister card

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of a labelimage of a label

image of a label
image of a label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of a labelimage of a label

image of a label
image of a label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of a labelimage of a label

image of a label
image of a label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1728288petrolatum 46.5 % Topical OintmentPSN6
1728288petrolatum 0.465 MG/MG Topical OintmentSCD6
1728288petrolatum 46.5 % Topical OintmentSY6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49967-500-01CeraVe Developed with Dermatologists Healing340 g in 1 JAROINTMENT3406
49967-500-02CeraVe Developed with Dermatologists Healing85 g in 1 TUBEOINTMENT856
49967-500-03CeraVe Developed with Dermatologists Healing144 g in 1 TUBEOINTMENT1446
49967-500-04CeraVe Developed with Dermatologists Healing2.5 g in 1 JAROINTMENT2.56
49967-500-04CeraVe Developed with Dermatologists Healing15 in 1 TRAYOINTMENT156
49967-500-05CeraVe Developed with Dermatologists Healing10 g in 1 TUBEOINTMENT106
49967-500-06CeraVe Developed with Dermatologists Healing2 in 1 CARTONOINTMENT26
49967-500-06CeraVe Developed with Dermatologists Healing10 g in 1 TUBEOINTMENT106
49967-500-07CeraVe Developed with Dermatologists Healing53.6 g in 1 TUBEOINTMENT53.66
49967-500-08CeraVe Developed with Dermatologists Healing5 g in 1 JAROINTMENT56
49967-500-08CeraVe Developed with Dermatologists Healing1 in 1 BLISTER PACKOINTMENT16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49967-500CERAVE DEVELOPED WITH DERMATOLOGISTS HEALING (PETROLATUM) OINTMENT [L'OREAL USA PRODUCTS INC.]6Current NDC, Legacy NDC, 11 package rows20240101_1b3ad3e8-cbac-4a92-84e2-4f3ab4512d95.zip

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49967-50049967-500-01, 49967-500-02, 49967-500-03, 49967-500-04, 49967-500-05, 49967-500-06, 49967-500-07, 49967-500-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
PETROLATUM4T6H12BN9UACTIB
MINERAL OILT5L8T28FGPIACT
PARAFFINI9O0E3H2ZEIACT
CERESINQ1LS2UJO3AIACT
DIMETHICONE92RU3N3Y1OIACT
CERAMIDE 15THT33P7X7IACT
CERAMIDE 34370DF050BIACT
CERAMIDE 6 IIF1X8L2B00JIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
WATER059QF0KO0RIACT
SODIUM LAUROYL LACTYLATE7243K85WFOIACT
LAUROYL PROLINEHDI505B669IACT
CHOLESTEROL97C5T2UQ7JIACT
PHENOXYETHANOLHIE492ZZ3TIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TOCOPHEROLR0ZB2556P8IACT
HYALURONIC ACIDS270N0TRQYIACT
PANTHENOLWV9CM0O67ZIACT
PANTOLACTONEJ288D7O0JSIACT
PHYTOSPHINGOSINEGIN46U9Q2QIACT
XANTHAN GUMTTV12P4NEEIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT

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 HealingPETROLATUML'Oreal USA Products Inc.1b3ad3e8-cbac-4a92-84e2-4f3ab4512d952023-12-31WarningsExact identifier
ndc (package): 49967-500-07
ndc (package): 49967-500-08
ndc (package): 49967-500-05
ndc (package): 49967-500-06
ndc (package): 49967-500-03
ndc (package): 49967-500-01
ndc (package): 49967-500-02
ndc (package): 49967-500-04
ndc (product): 49967-500
ndc11 (package): 49967050001
ndc11 (package): 49967050006
ndc11 (package): 49967050003
ndc11 (package): 49967050005
ndc11 (package): 49967050007
ndc11 (package): 49967050008
ndc11 (package): 49967050002
ndc11 (package): 49967050004
spl id: 1c801d2d-efb6-497e-9c2d-9394436ec934
spl set id: 1b3ad3e8-cbac-4a92-84e2-4f3ab4512d95

Reported adverse events (FAERS/openFDA)#

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