FDA.reportPublic FDA data

CeraVe Developed with Dermatologists Baby Healing

Manufacturer
L'Oreal USA Products Inc. | Accupac, Inc.
Effective date
2023-12-31
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:06:18

Label at a glance#

ProductCeraVe Developed with Dermatologists Baby Healing
Active ingredientPETROLATUM
Label structure11 sections

Indications and uses

■ helps treat and prevent diaper rash ■ protects chafed skin due to diaper rash and helps seal out wetness

Dosage and administration

change wet and soiled diapers promptly cleanse the diaper area and allow to dry apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime exposure to wet diapers may be prolonged

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Petrolatum 46.5%

Purpose

OTC - PURPOSE SECTION

Skin protectant

Uses

INDICATIONS & USAGE SECTION

■ helps treat and prevent diaper rash

■ protects chafed skin due to diaper rash and helps seal out wetness

Warnings

WARNINGS SECTION

For external use only

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

  • change wet and soiled diapers promptly
  • cleanse the diaper area and allow to dry
  • apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime exposure to wet diapers may be prolonged

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

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DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1728288petrolatum 46.5 % Topical OintmentPSN4
1728288petrolatum 0.465 MG/MG Topical OintmentSCD4
1728288petrolatum 46.5 % Topical OintmentSY4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49967-870-01CeraVe Developed with Dermatologists Baby Healing85 g in 1 TUBEOINTMENT854

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49967-870CERAVE DEVELOPED WITH DERMATOLOGISTS BABY HEALING (PETROLATUM) OINTMENT [L'OREAL USA PRODUCTS INC.]4Current NDC, Legacy NDC, 1 package rows20240101_fe665bbc-1172-4f59-acc6-8d5c179693b6.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
49967-87049967-870-01

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
HYALURONIC ACIDS270N0TRQYIACT
CERAMIDE 15THT33P7X7IACT
CERAMIDE NP4370DF050BIACT
CERAMIDE APF1X8L2B00JIACT
PHENOXYETHANOLHIE492ZZ3TIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TOCOPHEROLR0ZB2556P8IACT
PHYTOSPHINGOSINEGIN46U9Q2QIACT
CHOLESTEROL97C5T2UQ7JIACT
SODIUM LAUROYL LACTYLATE7243K85WFOIACT
CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)F68VH75CJCIACT
PANTHENOLWV9CM0O67ZIACT
PANTOLACTONEJ288D7O0JSIACT
WATER059QF0KO0RIACT
LAUROYL PROLINEHDI505B669IACT
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 Baby HealingPETROLATUML'Oreal USA Products Inc.fe665bbc-1172-4f59-acc6-8d5c179693b62023-12-31WarningsExact identifier
ndc (package): 49967-870-01
ndc (product): 49967-870
ndc11 (package): 49967087001
spl id: 9c069b2b-de21-4002-9c09-6aca6da2a161
spl set id: fe665bbc-1172-4f59-acc6-8d5c179693b6

Reported adverse events (FAERS/openFDA)#

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