FDA.reportPublic FDA data

Zinc Oxide 40%

Manufacturer
ELEEO BRANDS LLC
Effective date
2025-08-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:11:04

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 wipe tip clean after each use reapply firmly to lock applicator when not in use

Storage and handling

store at 59°F to 87°F

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
  • wipe tip clean after each use
  • reapply firmly to lock applicator when not in use

Other Information

STORAGE AND HANDLING SECTION

  • store at 59°F to 87°F

Inactive Ingredients

INACTIVE INGREDIENT SECTION

beeswax, cod liver oil, glycerine, lanolin, sorbitan sesquioleate, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, tocopheryl acetate, petrolatum

Questions and comments?

OTC - QUESTIONS SECTION

1-877-469-8877

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

bebe

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79747-009-13Zinc Oxide 40%113 g in 1 TUBEOINTMENT1132
79747-009-13Zinc Oxide 40%1 in 1 BOXOINTMENT12

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
79747-00979747-009-13

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
LANOLIN7EV65EAW6HIACT
GLYCERINPDC6A3C0OXIACT
YELLOW WAX2ZA36H0S2VIACT
PETROLATUM4T6H12BN9UIACT
COD LIVER OILBBL281NWFGIACT
PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE255PIF62MSIACT
SORBITAN SESQUIOLEATE0W8RRI5W5AIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
STARCH, CORNO8232NY3SJIACT
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
Zinc Oxide 40%DIAPER RASH SKIN PROTECTENTELEEO BRANDS LLC2992285b-bcdb-c0da-e063-6294a90ac6502025-08-19WarningsExact identifier
ndc (package): 79747-009-13
ndc (product): 79747-009
ndc11 (package): 79747000913
spl id: 3cb8e59e-357b-cb5a-e063-6294a90a9257
spl set id: 2992285b-bcdb-c0da-e063-6294a90ac650

Reported adverse events (FAERS/openFDA)#

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