FDA.reportPublic FDA data

Koala Kubs Diaper Rash Cream

Manufacturer
Melaleuca, Inc.
Effective date
2025-03-20
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:58:48

Label at a glance#

ProductKoala Kubs Diaper Rash Cream
Active ingredientZINC OXIDE
Label structure12 sections

Indications and uses

Uses Helps treat and prevent diaper rash Protects chaffed skin due to diaper rash and helps seal out wetness

Dosage and administration

Directions Change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry Apply cream liberally and as often as necessary with each diaper change and especially at bedtime or anytime when exposure to wet diapers may be prolonged.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients

Zinc Oxide USP 15%

Purpose

OTC - PURPOSE SECTION

Purpose

Skin Protectant

Uses

OTC - WHEN USING SECTION

Uses

  • Helps treat and prevent diaper rash
  • Protects chaffed skin due to diaper rash and helps seal out wetness

When using this product

OTC - WHEN USING SECTION

When using this product

  • do not get into eyes

Stop use and ask doctor if

OTC - STOP USE SECTION

Stop use and ask doctor if

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Directions

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

Other Information

OTHER SAFETY INFORMATION

Other Information

  • to open, twist off cap and remove quality seal
  • do not use if quality seal is broken
  • store at room temperature

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive Ingredients: water, decyl oleate, oleyl erucate, dicaprylyl ether, polyglyceryl-2 dipolyhydroxystearate, glycerin, polyglyceryl-3 diisostearate, magnesium stearate, sodium chloride, zinc stearate, benzyl alcohol, glycine soja (soybean) oil, sodium benzoate, ethylhexylglycerin, potassium sorbate, calendula officinalis (marigold) flower extract, tocopherol

Warnings

WARNINGS SECTION

For external use only

INDICATIONS & USAGE SECTION

Purpose

Skin Protectant

Uses

  • Helps treat and prevent diaper rash
  • Protects chafed skin due to diaper rash and helps seal out wetness

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54473-333-032025-04-07C16284748780-12cef2736-780f-d83d-e063-dadaa90ab31fKoala Kubs Diaper Rash Cream
54473-333-032025-01-30C16284748780-12cef2736-780f-d83d-e063-dadaa90ab31fKoala Kubs Diaper Rash Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54473-333-03Koala Kubs Diaper Rash Cream88 mL in 1 TUBECREAM883

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54473-333KOALA KUBS DIAPER RASH CREAM (DIAPER RASH CREAM) CREAM [MELALEUCA, INC.]3Current NDC, Legacy NDC, 1 package rows20250409_c6b3b0dd-22a8-16f7-e053-2a95a90a51ea.zip

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54473-33354473-333-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
ETHYLHEXYLGLYCERIN147D247K3PIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
WATER059QF0KO0RIACT
DECYL OLEATEZGR06DO97TIACT
TOCOPHEROLR0ZB2556P8IACT
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE9229XJ4V12IACT
SOYBEAN OIL241ATL177AIACT
ZINC STEARATEH92E6QA4FVIACT
OLEYL ERUCATE753W099NQ6IACT
SODIUM BENZOATEOJ245FE5EUIACT
GLYCERINPDC6A3C0OXIACT
DICAPRYLYL ETHER77JZM5516ZIACT
POLYGLYCERYL-3 DIISOSTEARATE46P231IQV8IACT
MAGNESIUM STEARATE70097M6I30IACT
SODIUM CHLORIDE451W47IQ8XIACT
BENZYL ALCOHOLLKG8494WBHIACT
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
Koala Kubs Diaper Rash CreamDIAPER RASH CREAMMelaleuca, Inc.c6b3b0dd-22a8-16f7-e053-2a95a90a51ea2025-03-20WarningsExact identifier
ndc (package): 54473-333-03
ndc (product): 54473-333
ndc11 (package): 54473033303
spl id: 30ce75fa-69c6-932d-e063-6294a90a3a29
spl set id: c6b3b0dd-22a8-16f7-e053-2a95a90a51ea

Reported adverse events (FAERS/openFDA)#

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