FDA.reportPublic FDA data

CALENDULA DIAPER RASH CREAM

Manufacturer
Weleda AG | Weleda, Inc.
Effective date
2017-11-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:09:53

Label at a glance#

ProductCALENDULA DIAPER RASH
Active ingredientZINC OXIDE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Zinc Oxide 12%

OTC - PURPOSE SECTION

Purpose

Diaper Rash Cream

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Store out of reach of children.

INDICATIONS & USAGE SECTION

Uses

Offers temporary, quick and effective relief for minor skin irritations due to diaper rash.

Minor skin irritations.

Reliable protection from dampness.

WARNINGS SECTION

Warnings

External use only.

Avoid contact with eyes.

Store at controlled room temperature, out of reach of children.

Do not use if safety seal under cap is broken or missing.

DOSAGE & ADMINISTRATION SECTION

Directions

Cleanse area, pat dry, then apply a thin layer of cream.

Apply to the whole diaper area after careful cleaning.

INACTIVE INGREDIENT SECTION

Inactive Ingredients (USA) / Non-Medicinal Ingredients (Canada):

Beeswax, Calendula Flower Extract, Cananga Oil, Chamomile Flower Extract, Citrus Aurantium Leafy Twig (Petitgrain) Oil, Clary Sage Oil, Glyceryl Linoleate, Hectorite, Lanolin, Lavender Oil, Orange Oil, Rosemary Oil, Sage Oil, Sesame Seed Oil, Styrax Tonkinensis Resin, Sweet Almond Oil, Water.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Weleda

Since 1921

Baby

Calendula

Diaper Rash Cream

Relieves and protects

Crème contre l'Erythème Fessier

Soulage et protège

Certified Natural Baby Care

Le Soin Naturel Authentique

NPN 80005250

NET WT / POIDS NET 0.22 OZ (6.3g)

MINI BOXMINI BOXMINI TUBEMINI TUBE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Weleda

Since 1921

Baby

Calendula

Diaper Rash Cream

Relieves and protects

Crème contre l`Erythème Fessier

Soulage et protège

Certified Natural Baby Care

Le Soin Naturel Authentique

NPN 80005250

NET WT / POIDS NET 2.9 OZ (81g)

LARGE BOXLARGE BOX

PACKAGE INSERT PAGE 1PACKAGE INSERT PAGE 1

LARGE TUBELARGE TUBEPACKAGE INSERT PAGE 2PACKAGE INSERT PAGE 2

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0201-40080201-4008-53, 0201-4008-21

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
ZINC OXIDESOI2LOH54ZACTIB
YELLOW WAX2ZA36H0S2VIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
CANANGA OIL8YOY78GNNXIACT
CHAMOMILEFGL3685T2XIACT
CITRUS AURANTIUM LEAFY TWIG OIL5K6H1IMT3DIACT
CLARY SAGE OIL87L0D4U3M0IACT
GLYCERYL MONOLINOLEATE4763AXI84LIACT
HECTORITE08X4KI73EZIACT
LANOLIN7EV65EAW6HIACT
LAVENDER OILZBP1YXW0H8IACT
ORANGE OILAKN3KSD11BIACT
ROSEMARY OIL8LGU7VM393IACT
SAGE OILU27K0H1H2OIACT
SESAME OILQX10HYY4QVIACT
STYRAX TONKINENSIS RESINQB299X2IBDIACT
ALMOND OIL66YXD4DKO9IACT
WATER059QF0KO0RIACT

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
6292a1ab-e513-4f9d-b740-61f92d48086fc71b2ed3-1c60-4450-b40d-17d99d64ae942020-11-17WarningsExact identifier
spl set id: c71b2ed3-1c60-4450-b40d-17d99d64ae94

Reported adverse events (FAERS/openFDA)#

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