FDA.reportPublic FDA data

Leader Diaper Rash Cream

Manufacturer
Cardinal Health
Effective date
2018-08-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:53:05

Label at a glance#

ProductLeader Diaper Rash Cream
Active ingredientZINC OXIDE
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 paste 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

Zinc Oxide 40%

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • change wet and soiled diapers promptly
  • cleanse the diaper area, and allow to dry
  • apply paste 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 between 20° to 25°C (68° to 77°F)
  • may stain clothing

Inactive Ingredients

INACTIVE INGREDIENT SECTION

white soft paraffine, COD liver oil, lanoline, talcum, glycerine, sorbitan soquioleate, beeswax, tocopheryl acetate, fragrance.

Questions?

OTC - QUESTIONS SECTION

1-888-DYNAREX

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CR1189LABELCR1189LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
37205-981-132025-05-15C16284748780-19d75b9cf-df37-f424-e053-dadaa90a57ceCR-1189
37205-981-132020-01-31C16284748780-19d75b9cf-df37-f424-e053-dadaa90a57ceCR-1189

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
37205-98137205-981-13

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
COD LIVER OILBBL281NWFGIACT
LANOLIN7EV65EAW6HIACT
TALC7SEV7J4R1UIACT
GLYCERINPDC6A3C0OXIACT
SORBITAN SESQUIOLEATE0W8RRI5W5AIACT
YELLOW WAX2ZA36H0S2VIACT
LIQUID PETROLEUM6ZAE7X688JIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
ZINC OXIDESOI2LOH54ZACTIB

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
da55eab7-dfa6-45f3-8801-aae76d34581372896ba2-975f-50ff-e053-2991aa0a6af82025-05-12WarningsExact identifier
spl set id: 72896ba2-975f-50ff-e053-2991aa0a6af8

Reported adverse events (FAERS/openFDA)#

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