FDA.reportPublic FDA data

Baby Skin Protectant

Manufacturer
Cardinal Health
Effective date
2026-10-06
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
daily-update
Hydrated at
2026-10-10 01:02:21

Label at a glance#

ProductLeader Baby Skin Protectant
Active ingredientPETROLATUM
Label structure9 sections

Indications and uses

Helps treat and prevent diaper rash Protects chafed skin associated with diaper rash and helps protect from wetness Temporarily protects minor cuts, scrapes,and burns Temporarily protects and helps relieve chapped, or cracked skin and lips Helps protect skin from the drying effects of wind and cold weather

Dosage and administration

Apply as needed or as directed by a physician For diaper rash, 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 when exposure to wet diapers may be prolonged.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Petrolatum 41%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

  • Helps treat and prevent diaper rash
  • Protects chafed skin associated with diaper rash and helps protect from wetness
  • Temporarily protects minor cuts, scrapes,and burns
  • Temporarily protects and helps relieve chapped, or cracked skin and lips
  • Helps protect skin from the drying effects of wind and cold weather

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

do not get in the eyes

Stop us 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

Do not use

OTC - DO NOT USE SECTION

  • On deep 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 Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply as needed or as directed by a physician
  • For diaper rash, 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 when exposure to wet diapers may be prolonged.

Other Information

OTHER SAFETY INFORMATION

  • Store at room temperature between 15º-30°C (59°-86°F)
  • Do not use if safety seal is broken or missing

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Ceresin, Dexpanthenol, Glycerin, Lanolin Alcohols, Mineral Oil

Questions and Comments?

OTC - QUESTIONS SECTION

1-888-396-2739

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CR-5684378 IN MASTERCR-5684378 IN MASTER

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130096295140514GTIN-13: 0096295140514
EAN-13: 0096295140514
GTIN-12: 096295140514
UPC-A: 096295140514
GTIN storage (14 digits): 00096295140514		CR-5684378 IN MASTER (R210309-1).jpg

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0079-1GM - Gram70000-00790d410365-49dd-46c5-b58e-a62e667c577012021-11-09

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-007970000-0079-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
PETROLATUM4T6H12BN9UACTIB
GLYCERINPDC6A3C0OXIACT
DEXPANTHENOL1O6C93RI7ZIACT
LANOLIN ALCOHOLS884C3FA9HEIACT
MINERAL OILT5L8T28FGPIACT
CERESINQ1LS2UJO3AIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
72025-11-25full-release2026-06-01 01:18:08

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
Leader Baby Skin ProtectantBABY SKIN PROTECTANTCardinal Healthb83ee0e1-d1a3-6c4a-e053-2a95a90aec392025-11-25WarningsExact identifier
ndc (package): 70000-0079-1
ndc (product): 70000-0079
ndc11 (package): 70000007901
spl set id: b83ee0e1-d1a3-6c4a-e053-2a95a90aec39

Reported adverse events (FAERS/openFDA)#

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