FDA.reportPublic FDA data

CR-1190 Zinc Oxide 25% Skin Protectant NDC 70000-0488-1

Manufacturer
Cardinal Health
Effective date
2026-10-06
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
daily-update
Hydrated at
2026-10-10 01:03:10

Label at a glance#

ProductSkin Protectant
Active ingredientZINC OXIDE
Label structure9 sections

Indications and uses

Helps treat and prevent diaper rash Dries the oozing and weeping of poison: ivy, oak, sumac

Dosage and administration

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. for poison ivy, oak, and sumac: apply as needed.

Storage and handling

Store at room temperature

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 25%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

  • Helps treat and prevent diaper rash
  • Dries the oozing and weeping of poison: ivy, oak, sumac

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

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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.
    • for poison ivy, oak, and sumac: apply as needed.

Other Information

STORAGE AND HANDLING SECTION

Store at room temperature

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Cetostearyl Alcohol, Light Mineral Oil, Macrogol Cetostearyl Ether 12, White Soft Paraffin

Questions and Comments?

OTC - QUESTIONS SECTION

1-888-396-2739

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CR-1190 Zinc Oxide Ointment PDPCR-1190 Zinc Oxide Ointment PDP

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0488-1GM - Gram70000-0488bcb23a65-72e1-49a0-a82a-2ed2811da35f12020-05-08

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-048870000-0488-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
CETEARETH-127V4MR24V5PIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
LIGHT MINERAL OILN6K5787QVPIACT
PETROLATUM4T6H12BN9UIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
92025-11-25full-release2026-06-01 01:18:06

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
Skin ProtectantZINC OXIDE 25%Cardinal Health8abda4ad-2ef7-9428-e053-2a95a90ac0fb2025-11-25WarningsExact identifier
ndc (package): 70000-0488-1
ndc (product): 70000-0488
ndc11 (package): 70000048801
spl set id: 8abda4ad-2ef7-9428-e053-2a95a90ac0fb

Reported adverse events (FAERS/openFDA)#

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