CALENDULA DIAPER RASH CREAM

Manufacturer: Weleda A.G. Schwäbisch Gmünd, Zweigniederlassung der Weled
Effective date: 2013-06-27
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:35:48

Label at a glance#

ProductCALENDULA DIAPER RASH CREAM

Active ingredientZINC OXIDE

Label structure10 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Weleda

Since 1921

Baby & Child

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 2.8 OZ (81g)

LARGE TUBEPACKAGE INSERT PAGE 2PACKAGE INSERT PAGE 1LARGE BOX

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Zinc Oxide 12%

OTC - PURPOSE SECTION

Purpose

Diaper Rash Cream

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all medicines out of the 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.

Keep this and all medicines out of the reach of children.

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 Benzoin Resin, Sweet Almond Oil, Water.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Weleda

Since 1921

Baby & Child

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 0.4 OZ (10.8g)

MINI TUBE

MINI BOX

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Weleda

Since 1921

Baby & Child

Calendula

Diaper Rash Cream

Crème contre l'Erythème Fessier

Certified Natural Baby Care

Le Soin Naturel Authentique

NET WT / POIDS NET 0.05 OZ (1.5g)

SACHET

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
417994	zinc oxide 12 % Topical Cream	PSN	1
417994	zinc oxide 120 MG/ML Topical Cream	SCD	1
417994	zinc oxide 12 % Topical Cream	SY	1
417994	ZNO 120 MG/ML Topical Cream	SY	1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0164-2189-49	2019-11-27	C162847	48780-1	9855d018-d91c-cd31-e053-dbdaa90ab51a	CALENDULA DIAPER RASH CREAM
0164-2189-53	2019-11-27	C162847	48780-1	9855d018-d91c-cd31-e053-dbdaa90ab51a	CALENDULA DIAPER RASH CREAM
0164-2189-54	2019-11-27	C162847	48780-1	9855d018-d91c-cd31-e053-dbdaa90ab51a	CALENDULA DIAPER RASH CREAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0164-2189-49	CALENDULA DIAPER RASH CREAM	1.5 g in 1 POUCH	CREAM	1.5	1
0164-2189-53	CALENDULA DIAPER RASH CREAM	81 g in 1 TUBE	CREAM	81	1
0164-2189-54	CALENDULA DIAPER RASH CREAM	10.8 g in 1 TUBE	CREAM	10.8	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0164-2189	CALENDULA DIAPER RASH CREAM (ZINC OXIDE) CREAM [WELEDA A.G. SCHW&AUML;BISCH GM&UUML;ND, ZWEIGNIEDERLASSUNG DER WELED]	1	Legacy NDC, 3 package rows	20130628_4ca9ff2c-c6c6-4838-bff6-3a431e904246.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	1
ZINC OXIDE	ACTIVE MOIETY	SOI2LOH54Z	1
ALMOND OIL	INACTIVE INGREDIENT	66YXD4DKO9	1
CALENDULA OFFICINALIS FLOWER	INACTIVE INGREDIENT	P0M7O4Y7YD	1
CANANGA OIL	INACTIVE INGREDIENT	8YOY78GNNX	1
CHAMOMILE	INACTIVE INGREDIENT	FGL3685T2X	1
CITRUS AURANTIUM LEAFY TWIG OIL	INACTIVE INGREDIENT	5K6H1IMT3D	1
CLARY SAGE OIL	INACTIVE INGREDIENT	87L0D4U3M0	1
GLYCERYL MONOLINOLEATE	INACTIVE INGREDIENT	4763AXI84L	1
HECTORITE	INACTIVE INGREDIENT	08X4KI73EZ	1
LANOLIN	INACTIVE INGREDIENT	7EV65EAW6H	1
LAVENDER OIL	INACTIVE INGREDIENT	ZBP1YXW0H8	1
ORANGE OIL	INACTIVE INGREDIENT	AKN3KSD11B	1
ROSEMARY OIL	INACTIVE INGREDIENT	8LGU7VM393	1
SAGE OIL	INACTIVE INGREDIENT	U27K0H1H2O	1
SESAME OIL	INACTIVE INGREDIENT	QX10HYY4QV	1
STYRAX BENZOIN RESIN	INACTIVE INGREDIENT	FE663Z8IRO	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1
YELLOW WAX	INACTIVE INGREDIENT	2ZA36H0S2V	1

Products#

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

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

CALENDULA DIAPER RASH CREAM
ZINC OXIDE
YELLOW WAX
CALENDULA OFFICINALIS FLOWER
CANANGA OIL
CHAMOMILE
CITRUS AURANTIUM LEAFY TWIG OIL
CLARY SAGE OIL
GLYCERYL MONOLINOLEATE
HECTORITE
LANOLIN
LAVENDER OIL
ORANGE OIL
ROSEMARY OIL
SAGE OIL
SESAME OIL
STYRAX BENZOIN RESIN
ALMOND OIL
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0164-2189	0164-2189-53, 0164-2189-54, 0164-2189-49

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
Name	UNII	Kind
ZINC OXIDE	SOI2LOH54Z	ACTIB
YELLOW WAX	2ZA36H0S2V	IACT
CALENDULA OFFICINALIS FLOWER	P0M7O4Y7YD	IACT
CANANGA OIL	8YOY78GNNX	IACT
CHAMOMILE	FGL3685T2X	IACT
CITRUS AURANTIUM LEAFY TWIG OIL	5K6H1IMT3D	IACT
CLARY SAGE OIL	87L0D4U3M0	IACT
GLYCERYL MONOLINOLEATE	4763AXI84L	IACT
HECTORITE	08X4KI73EZ	IACT
LANOLIN	7EV65EAW6H	IACT
LAVENDER OIL	ZBP1YXW0H8	IACT
ORANGE OIL	AKN3KSD11B	IACT
ROSEMARY OIL	8LGU7VM393	IACT
SAGE OIL	U27K0H1H2O	IACT
SESAME OIL	QX10HYY4QV	IACT
STYRAX BENZOIN RESIN	FE663Z8IRO	IACT
ALMOND OIL	66YXD4DKO9	IACT
WATER	059QF0KO0R	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 30 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SESAME OIL	SESAME OIL	QX10HYY4QV	INJECTION / INTRAMUSCULAR	70 %v/v		Exact identifier — unii candidate 2 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	OINTMENT / RECTAL		105 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
ORANGE OIL	ORANGE OIL, COLD PRESSED	AKN3KSD11B	TABLET, CHEWABLE / ORAL	3.7 mg		Exact identifier — unii candidate 6 equally ranked IID candidates
ORANGE OIL	ORANGE OIL, COLD PRESSED	AKN3KSD11B	ELIXIR / ORAL	0.24 mg		Exact identifier — unii candidate 6 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	TABLET, EXTENDED RELEASE / ORAL	0.01 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
LAVENDER OIL	LAVENDER OIL	ZBP1YXW0H8	INHALANT / NASAL	NA		Exact identifier — unii candidate 2 equally ranked IID candidates
GLYCERYL MONOLINOLEATE	GLYCERYL MONOLINOLEATE	4763AXI84L	CAPSULE / ORAL		2408 mg	Exact identifier — unii candidate
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	TABLET / ORAL	3.22 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	CREAM / TOPICAL	5 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
ORANGE OIL	ORANGE OIL, COLD PRESSED	AKN3KSD11B	POWDER, FOR SUSPENSION / ORAL		4 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
LAVENDER OIL	LAVENDER OIL	ZBP1YXW0H8	GEL / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 2 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	CREAM / VAGINAL	2 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	SHAMPOO / TOPICAL	2 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	CAPSULE / ORAL		44 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
ORANGE OIL	ORANGE OIL, COLD PRESSED	AKN3KSD11B	LIQUID / ORAL	50 mg		Exact identifier — unii candidate 6 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	LOTION / TOPICAL	1.5 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	OINTMENT / TOPICAL	10 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	EMULSION / TOPICAL	0.25 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	TABLET, COATED / ORAL	213.7 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	OINTMENT / OPHTHALMIC	3 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
ALMOND OIL	ALMOND OIL	66YXD4DKO9	CREAM / TOPICAL	2 %w/w		Exact identifier — unii candidate
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	CAPSULE, EXTENDED RELEASE / ORAL	80.67 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
ORANGE OIL	ORANGE OIL, COLD PRESSED	AKN3KSD11B	SUSPENSION / ORAL		1 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	CREAM / TOPICAL		10 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	OINTMENT / TOPICAL	20 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	SPRAY / NASAL	NA		Exact identifier — unii candidate 9 equally ranked IID candidates
ORANGE OIL	ORANGE OIL, COLD PRESSED	AKN3KSD11B	TABLET / SUBLINGUAL	NA		Exact identifier — unii candidate 6 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 9 equally ranked IID candidates
SESAME OIL	SESAME OIL	QX10HYY4QV	CAPSULE / ORAL		2325 mg	Exact identifier — unii candidate 2 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	TABLET, DELAYED RELEASE / ORAL	0.1 mg		Exact identifier — unii candidate 9 equally ranked IID candidates

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
5f0f7acc-f134-43bb-9797-48e73a35e64f			4ca9ff2c-c6c6-4838-bff6-3a431e904246	2013-06-27	Warnings	Exact identifier spl id: 5f0f7acc-f134-43bb-9797-48e73a35e64f spl set id: 4ca9ff2c-c6c6-4838-bff6-3a431e904246

Reported adverse events (FAERS/openFDA)#

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