FDA.reportPublic FDA data

CR-1189 Zinc Oxide 40% NDC 70000-0469-1

Manufacturer
Cardinal Health
Effective date
2026-10-06
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
daily-update
Hydrated at
2026-10-10 01:03:49

Label at a glance#

ProductZinc Oxide 40%
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 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

Storage and handling

store at 20°C to 25°C (68°F to 77°F) may stain clothing

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

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • change wet and soiled diapers promptly
  • cleanse the diaper area
  • 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

STORAGE AND HANDLING SECTION

  • store at 20°C to 25°C (68°F to 77°F)
  • may stain clothing

Inactive Ingredients

INACTIVE INGREDIENT SECTION

beeswax, cod liver oil, fragrance, glycerine, lanolin, sorbitan sesquioleate, talc, tocopheryl acetate, petrolatum

Questions and comments?

OTC - QUESTIONS SECTION

1-888-396-2739

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CR-1189 Primary Display Panel 40% Zinc OxideCR-1189 Primary Display Panel 40% Zinc Oxide

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0469-1GM - Gram70000-0469e9da20b3-175e-46dc-a57d-307ef103964412020-01-03

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-046970000-0469-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
LANOLIN7EV65EAW6HIACT
GLYCERINPDC6A3C0OXIACT
YELLOW WAX2ZA36H0S2VIACT
PETROLATUM4T6H12BN9UIACT
COD LIVER OILBBL281NWFGIACT
SORBITAN SESQUIOLEATE0W8RRI5W5AIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TAPIOCA STARCH24SC3U704IIACT
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)59Z907ZB69IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
82025-11-25full-release2026-06-01 01:18:05

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
Zinc Oxide 40%DIAPER RASH SKIN PROTECTENTCardinal Health80c24e21-6aba-0c05-e053-2a91aa0a657f2025-11-25WarningsExact identifier
ndc (package): 70000-0469-1
ndc (product): 70000-0469
ndc11 (package): 70000046901
spl set id: 80c24e21-6aba-0c05-e053-2a91aa0a657f

Reported adverse events (FAERS/openFDA)#

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