FDA.reportPublic FDA data

Leader Zinc Oxide

Manufacturer
Cardinal Health 110,Inc.
Effective date
2024-01-18
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:07:33

Label at a glance#

ProductLeader Zinc Oxide
Active ingredientZINC OXIDE
Label structure8 sections

Indications and uses

helps treat and prevent diaper rash. Protects chafed skin due to diaper rash and helps seal out wetness. dries the oozing and weeping of poison ivy, poison oak and poison sumac.

Dosage and administration

apply liberally as often as necessary For Diaper Rash change wet or soiled diapers promptly cleanse the diaper area and allow to dry apply ointment liberally, as often as necessary, with each diaper change and especially at bedtime or anytime when exposure to wet diapers may be prolonged For Poison Ivy, poison oak and poison sumac; cleanse the affect area and pat dry  apply ointment liberally, as often as necessar...

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Zinc oxide 20%

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.
  • dries the oozing and weeping of poison ivy, poison oak and poison sumac.

Warnings

WARNINGS SECTION

For external use only

OTC - WHEN USING SECTION

When using this product, avoid contact with the eyes

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • condition worsens
  • symptoms last more than 7 days to 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

  • apply liberally as often as necessary

For Diaper Rash

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

For Poison Ivy, poison oak and poison sumac;

  • cleanse the affect area and pat dry 
  • apply ointment liberally, as often as necessary, using a cotton ball, sterile swab or gauze
  • wash hands after use.

Inactive ingredients

INACTIVE INGREDIENT SECTION

mineral oil, petrolatum

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-222-1087

Store at room temperature 20 - 25°C (68° - 77°F).

Principal Display Panel – Jar Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Leader®       NDC 70000-0334-1

Zinc Oxide

Ointment USP•

Multi Purpose Skin Protectant 

provides soothing relief from poison ivy,

oak and sumac

Treats and prevents diaper rash

Net Wt 1 lb (454 g)

Principal Display Panel – Jar LabelPrincipal Display Panel – Jar Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198911zinc oxide 20 % Topical OintmentPSN3
198911zinc oxide 0.2 MG/MG Topical OintmentSCD3
198911zinc oxide 20 % Topical OintmentSY3
198911zinc oxide 200 MG per GM Topical OintmentSY3
198911ZNO 0.2 MG/MG Topical OintmentSY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0334-1Leader Zinc Oxide454 g in 1 JAROINTMENT4543

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0334LEADER ZINC OXIDE (ZINC OXIDE) OINTMENT [CARDINAL HEALTH 110,INC.]3Current NDC, Legacy NDC, 1 package rows20240119_4d675dfd-6ea9-4aa7-a4ff-bb84f87ff7d1.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0334-1GM - Gram70000-0334720ca912-e7e9-4858-ae4f-0471ef0eb7e612019-09-05

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-033470000-0334-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
MINERAL OILT5L8T28FGPIACT
PETROLATUM4T6H12BN9UIACT

Source Document#

Source XML · Source PDF

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 Zinc OxideZINC OXIDECardinal Health 110,Inc.4d675dfd-6ea9-4aa7-a4ff-bb84f87ff7d12024-01-18WarningsExact identifier
ndc (package): 70000-0334-1
ndc (product): 70000-0334
ndc11 (package): 70000033401
spl id: 4e63f6a0-1c7c-47df-b503-1b9cf3797f9c
spl set id: 4d675dfd-6ea9-4aa7-a4ff-bb84f87ff7d1

Reported adverse events (FAERS/openFDA)#

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