CeraVe

Manufacturer
Valeant Pharmaceuticals North America LLC | Accupac, Inc.
Effective date
2017-01-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:20:26

Label at a glance#

ProductCeraVe Baby Healing
Active ingredientPETROLATUM
Label structure9 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 (ointment)

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 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

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, 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

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW

CeraVe®

DEVELOPED WITH DERMATOLOGISTS

baby

Healing

Ointment

Helps treat and prevent

diaper rash

Skin Protectant

With ceramides

Lanolin Free

Net Wt. 3 OZ (85 g)

[icon/seal] National Eczema Association

CeraVe Baby Healing Ointment 3 oz Tube
CeraVe Baby Healing Ointment 3 oz Tube

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0187-2487-032021-05-11C16284748780-19d75b9d0-707b-f424-e053-dadaa90a57ceDrug Facts
0187-2487-032020-01-31C16284748780-19d75b9d0-707b-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
0187-24870187-2487-03

Ingredients#

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

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

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
e59fc6a9-e203-4972-84a6-be305d1cb61a0fce92d9-737f-4cfa-a00f-177e1d85e8912017-01-26WarningsExact identifier
spl set id: 0fce92d9-737f-4cfa-a00f-177e1d85e891

Reported adverse events (FAERS/openFDA)#

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