BABY DIAPER RASH

Manufacturer: PUREMEDY
Effective date: 2024-01-11
Label type: HUMAN OTC DRUG LABEL
Version: 15
Source: full-release
Hydrated at: 2026-06-01 02:25:35

Label at a glance#

ProductBABY DIAPER RASH

Active ingredientCALENDULA OFFICINALIS FLOWER, SAMBUCUS NIGRA FLOWER

Label structure10 sections

Storage and handling

STORE IN A COOL DRY PLACE OR REFRIGERATE.

Contacts and useful links#

PhoneLabel contact818-851-9014

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS

ORG. CALENDULA OFFICINALIS (1X) HPUS) (MARIGOLD)

ORG. SAMBUCUS NIGRA (1X) HPUS (ELDERBERRY)

OTC - PURPOSE SECTION

PURPOSE

SOOTHES RASH, IRRITATION

REMEDY FOR SWELLING

INDICATIONS & USAGE SECTION

USES: TO RELIEVE SYMPTOMS ASSOCIATED WITH DIAPER RASH AND MINOR SKIN IRRITATIONS. SOOTHES SKINS AND PROTECTS AGAINST MOISTURE TP PROMOTE HEALING.

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS: APPLY TO CLEAN SKIN AFTER EACH DIAPER CHANGE OR AS DIRECTED BY YOUR PHYSICIAN. MAY ALSO BE USED AS A DAILY SKIN PROTECTANT.

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS: ORG. OLIVE OIL, ORG. BEESWAX, MILD PROPRIETARY BLEND OF PINE AND FIR EXTRACTS, ORG. COCOA BUTTER, ORG. MILK THISTLE, ORG. ST. JOHN'S WORT, ORG. ALOE VERA GEL, ORG. NON-GMO VITAMIN E

WARNINGS SECTION

WARNINGS: DO NOT USE IF ALLERGIC TO OR SENSITIVE TO ANY INGREDIENT IN THIS SALVE. TEST FOR ALLERGY BY RUBBING A SMALL AMOUNT ON SKIN BEFORE USE. IF CONDITION PERSISTS OR WORSENS AFTER 3 DAYS SEE A DOCTOR. AVOID DIRECT CONTACT WITH EYES. USE ONLY AS DIRECTED. KEEP ALL DRUGS OUT OF USE OF CHILDREN. SAFE TO USE FOR ALL AGES.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP ALL DRUGS OUT OF REACH OF CHILDREN.

STORAGE AND HANDLING SECTION

STORE IN A COOL DRY PLACE OR REFRIGERATE.

OTC - QUESTIONS SECTION

CUSTOMER SERVICE 818-851-9014

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1oz_BabyDiaperRash

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ebc62596-fc97-4d03-9483-7ba095d25db7	Product name	1	20151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
52810-216-11	2025-07-29	C162847	48780-1	9d75b9d1-2070-f424-e053-dadaa90a57ce	DIAPER RASH RELIEF (52810-216)
52810-217-11	2020-05-14	C162847	48780-1	9d75b9d1-2070-f424-e053-dadaa90a57ce	DIAPER RASH RELIEF (52810-216)
52810-217-11	2020-01-31	C162847	48780-1	9d75b9d1-2070-f424-e053-dadaa90a57ce	DIAPER RASH RELIEF (52810-216)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
52810-216-11	BABY DIAPER RASH	30 mL in 1 JAR	SALVE	30		15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52810-216	BABY DIAPER RASH (CALENDULA OFFICINALIS FLOWER, SAMBUCUS NIGRA FLOWER) SALVE [PUREMEDY]	15	Legacy NDC, 1 package rows	20240112_1b81ef0c-2ab6-4f1b-a062-06a776491bb2.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
CALENDULA OFFICINALIS FLOWER	ACTIVE INGREDIENT	P0M7O4Y7YD	5
SAMBUCUS NIGRA FLOWER	ACTIVE INGREDIENT	07V4DX094T	5
CALENDULA OFFICINALIS FLOWER	ACTIVE MOIETY	P0M7O4Y7YD	5
SAMBUCUS NIGRA FLOWER	ACTIVE MOIETY	07V4DX094T	5
.ALPHA.-TOCOPHEROL	INACTIVE INGREDIENT	H4N855PNZ1	5
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	5
CANADA BALSAM	INACTIVE INGREDIENT	K304VI98I3	5
COCOA BUTTER	INACTIVE INGREDIENT	512OYT1CRR	5
OLIVE OIL	INACTIVE INGREDIENT	6UYK2W1W1E	5
SILYBUM MARIANUM SEED	INACTIVE INGREDIENT	U946SH95EE	5
ST. JOHN'S WORT	INACTIVE INGREDIENT	UFH8805FKA	5
YELLOW WAX	INACTIVE INGREDIENT	2ZA36H0S2V	5

Products#

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

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

BABY DIAPER RASH
CALENDULA OFFICINALIS FLOWER, SAMBUCUS NIGRA FLOWER
OLIVE OIL
YELLOW WAX
CANADA BALSAM
COCOA BUTTER
SILYBUM MARIANUM SEED
ST. JOHN'S WORT
ALOE VERA LEAF
.ALPHA.-TOCOPHEROL
CALENDULA OFFICINALIS FLOWER
SAMBUCUS NIGRA FLOWER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
52810-216	52810-216-11

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
Name	UNII	Kind
OLIVE OIL	6UYK2W1W1E	IACT
YELLOW WAX	2ZA36H0S2V	IACT
CANADA BALSAM	K304VI98I3	IACT
COCOA BUTTER	512OYT1CRR	IACT
SILYBUM MARIANUM SEED	U946SH95EE	IACT
ST. JOHN'S WORT	UFH8805FKA	IACT
ALOE VERA LEAF	ZY81Z83H0X	IACT
.ALPHA.-TOCOPHEROL	H4N855PNZ1	IACT
CALENDULA OFFICINALIS FLOWER	P0M7O4Y7YD	ACTIB
SAMBUCUS NIGRA FLOWER	07V4DX094T	ACTIB

Source Document#

Source XML · Source PDF

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 · 26 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
.ALPHA.-TOCOPHEROL	.ALPHA.-TOCOPHEROL	H4N855PNZ1	TABLET, CHEWABLE / ORAL	0.1 mg		Exact identifier — unii candidate 10 equally ranked IID candidates
OLIVE OIL	OLIVE OIL	6UYK2W1W1E	SOLUTION / ORAL	425 mg/1ml		Exact identifier — unii candidate 5 equally ranked IID candidates
.ALPHA.-TOCOPHEROL	.ALPHA.-TOCOPHEROL	H4N855PNZ1	INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS	0.64 mg		Exact identifier — unii candidate 10 equally ranked IID candidates
OLIVE OIL	OLIVE OIL	6UYK2W1W1E	SOAP / TOPICAL	NA		Exact identifier — unii candidate 5 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	TABLET, COATED / ORAL	213.7 mg		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
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	CREAM / TOPICAL	5 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
CANADA BALSAM	CANADA BALSAM	K304VI98I3	LOTION / TOPICAL	0.5 %w/w		Exact identifier — unii candidate
OLIVE OIL	OLIVE OIL	6UYK2W1W1E	CAPSULE / ORAL	NA		Exact identifier — unii candidate 5 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
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 9 equally ranked IID candidates
.ALPHA.-TOCOPHEROL	.ALPHA.-TOCOPHEROL	H4N855PNZ1	TABLET / ORAL		2 mg	Exact identifier — unii candidate 10 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	CAPSULE, EXTENDED RELEASE / ORAL	80.67 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
.ALPHA.-TOCOPHEROL	.ALPHA.-TOCOPHEROL	H4N855PNZ1	TABLET, FILM COATED / ORAL		246 mg	Exact identifier — unii candidate 10 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	TABLET / ORAL	3.22 mg		Exact identifier — unii candidate 9 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
COCOA BUTTER	COCOA BUTTER	512OYT1CRR	SUPPOSITORY / RECTAL	2280 mg		Exact identifier — unii candidate
.ALPHA.-TOCOPHEROL	.ALPHA.-TOCOPHEROL	H4N855PNZ1	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 10 equally ranked IID candidates
OLIVE OIL	OLIVE OIL	6UYK2W1W1E	LOTION / TOPICAL		32468 mg	Exact identifier — unii candidate 5 equally ranked IID candidates
.ALPHA.-TOCOPHEROL	.ALPHA.-TOCOPHEROL	H4N855PNZ1	SYSTEM / TOPICAL	0.1 mg		Exact identifier — unii candidate 10 equally ranked IID candidates
.ALPHA.-TOCOPHEROL	.ALPHA.-TOCOPHEROL	H4N855PNZ1	FILM, SOLUBLE / BUCCAL	0.07 mg		Exact identifier — unii candidate 10 equally ranked IID candidates
.ALPHA.-TOCOPHEROL	.ALPHA.-TOCOPHEROL	H4N855PNZ1	TABLET, EXTENDED RELEASE / ORAL		4 mg	Exact identifier — unii candidate 10 equally ranked IID candidates
OLIVE OIL	OLIVE OIL	6UYK2W1W1E	SOLUTION / TOPICAL	0.6 %w/w		Exact identifier — unii candidate 5 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	OINTMENT / TOPICAL	20 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
.ALPHA.-TOCOPHEROL	.ALPHA.-TOCOPHEROL	H4N855PNZ1	SOLUTION / ORAL	1.05 mg/1ml		Exact identifier — unii candidate 10 equally ranked IID candidates
.ALPHA.-TOCOPHEROL	.ALPHA.-TOCOPHEROL	H4N855PNZ1	CAPSULE / ORAL		16 mg	Exact identifier — unii candidate 10 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
0eb2acb8-5c64-5ed8-e063-6294a90ac802			1b81ef0c-2ab6-4f1b-a062-06a776491bb2	2024-01-11	Warnings	Exact identifier spl id: 0eb2acb8-5c64-5ed8-e063-6294a90ac802 spl set id: 1b81ef0c-2ab6-4f1b-a062-06a776491bb2

Reported adverse events (FAERS/openFDA)#

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