BABY ACNE

Manufacturer: PUREMEDY
Effective date: 2024-01-11
Label type: HUMAN OTC DRUG LABEL
Version: 6
Source: full-release
Hydrated at: 2026-06-01 02:25:34

Label at a glance#

ProductBABY ACNE

Active ingredientCALENDULA OFFICINALIS FLOWER, SAMBUCUS NIGRA FLOWER, THUJA OCCIDENTALIS LEAF

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 (ELDER BARK AND FLOWER)

ORG. THUJA OCCIDENTALIS (1X) HPUS (ARBOR VITAE)

OTC - PURPOSE SECTION

PURPOSE

SKIN HEALING AGENT

REMEDY FOR SWELLING

REMEDY FOR ACNE

INDICATIONS & USAGE SECTION

USES: TO RELIEVE SYMPTOMS ASSOCIATED WITH BABY ACNE.

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS: APPLY TOPICALLY AS NEEDED OR AS DIRECTED BY YOUR PHYSICIAN.

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS: ORG. OLIVE OIL, ORG. BEESWAX, ORG. COCOA BUTTER, MILD PROPRIETARY BLEND OF PINE AND FIR EXTRACTS

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

BABY ACNE

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
52810-214-11	2025-07-29	C162847	48780-1	9855e2a2-4f0b-60a7-e053-dbdaa90a05bd	BABY ACNE (52810-214)
52810-214-11	2020-04-16	C162847	48780-1	9855e2a2-4f0b-60a7-e053-dbdaa90a05bd	BABY ACNE (52810-214)
52810-214-11	2019-11-27	C162847	48780-1	9855e2a2-4f0b-60a7-e053-dbdaa90a05bd	BABY ACNE (52810-214)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
52810-214-11	BABY ACNE	30 mL in 1 JAR	SALVE	30		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52810-214	BABY ACNE (CALENDULA OFFICINALIS FLOWER, SAMBUCUS NIGRA FLOWER, THUJA OCCIDENTALIS) SALVE [PUREMEDY]	6	Legacy NDC, 1 package rows	20240112_09b4e4a7-f69a-4bfd-8ecc-eac4543f7ab1.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
CALENDULA OFFICINALIS FLOWER	ACTIVE INGREDIENT	P0M7O4Y7YD	2
SAMBUCUS NIGRA FLOWER	ACTIVE INGREDIENT	07V4DX094T	2
THUJA OCCIDENTALIS LEAF	ACTIVE INGREDIENT	0T0DQN8786	2
CALENDULA OFFICINALIS FLOWER	ACTIVE MOIETY	P0M7O4Y7YD	2
SAMBUCUS NIGRA FLOWER	ACTIVE MOIETY	07V4DX094T	2
THUJA OCCIDENTALIS LEAF	ACTIVE MOIETY	0T0DQN8786	2
CANADA BALSAM	INACTIVE INGREDIENT	K304VI98I3	2
COCOA BUTTER	INACTIVE INGREDIENT	512OYT1CRR	2
OLIVE OIL	INACTIVE INGREDIENT	6UYK2W1W1E	2
YELLOW WAX	INACTIVE INGREDIENT	2ZA36H0S2V	2

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

BABY ACNE
CALENDULA OFFICINALIS FLOWER, SAMBUCUS NIGRA FLOWER, THUJA OCCIDENTALIS
OLIVE OIL
YELLOW WAX
COCOA BUTTER
CANADA BALSAM
CALENDULA OFFICINALIS FLOWER
SAMBUCUS NIGRA FLOWER
THUJA OCCIDENTALIS LEAF

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
52810-214	52810-214-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
OLIVE OIL	6UYK2W1W1E	IACT
YELLOW WAX	2ZA36H0S2V	IACT
COCOA BUTTER	512OYT1CRR	IACT
CANADA BALSAM	K304VI98I3	IACT
CALENDULA OFFICINALIS FLOWER	P0M7O4Y7YD	ACTIB
SAMBUCUS NIGRA FLOWER	07V4DX094T	ACTIB
THUJA OCCIDENTALIS LEAF	0T0DQN8786	ACTIB

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 · 16 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
OLIVE OIL	OLIVE OIL	6UYK2W1W1E	SOLUTION / TOPICAL	0.6 %w/w		Exact identifier — unii candidate 5 equally ranked IID candidates
OLIVE OIL	OLIVE OIL	6UYK2W1W1E	CAPSULE / ORAL	NA		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
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	TABLET, DELAYED RELEASE / ORAL	0.1 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
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	CAPSULE / ORAL		44 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
OLIVE OIL	OLIVE OIL	6UYK2W1W1E	SOLUTION / ORAL	425 mg/1ml		Exact identifier — unii candidate 5 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 9 equally ranked IID candidates
COCOA BUTTER	COCOA BUTTER	512OYT1CRR	SUPPOSITORY / RECTAL	2280 mg		Exact identifier — unii candidate
OLIVE OIL	OLIVE OIL	6UYK2W1W1E	SOAP / TOPICAL	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 / ORAL	3.22 mg		Exact identifier — unii candidate 9 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
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	TABLET, COATED / ORAL	213.7 mg		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	LOTION / TOPICAL		32468 mg	Exact identifier — unii candidate 5 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
0eb2c553-cad9-7045-e063-6294a90ab7bd			09b4e4a7-f69a-4bfd-8ecc-eac4543f7ab1	2024-01-11	Warnings	Exact identifier spl id: 0eb2c553-cad9-7045-e063-6294a90ab7bd spl set id: 09b4e4a7-f69a-4bfd-8ecc-eac4543f7ab1

Reported adverse events (FAERS/openFDA)#

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