FDA.reportPublic FDA data

BABY SKIN

Manufacturer
PUREMEDY
Effective date
2021-10-06
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:15:14

Label at a glance#

ProductBABY SKIN
Active ingredientECHINACEA ANGUSTIFOLIA, SAMBUCUS NIGRA FLOWER, CALENDULA OFFICINALIS FLOWER, PINE NEEDLE OIL (PINUS SYLVESTRIS)
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS

PINUS SILVESTRIS (2X) HPUS (PINE RESIN)

ORG. SAMBUCUS NIGRA (3X) HPUS (ELDERBERRY)

ORG. CALENDULA OFFICINALIS (6X) HPUS (MARIGOLD)

ORG. ECHINACEA ANGUSTIFOLIA (6X) HPUS (ECHINACEA)

OTC - PURPOSE SECTION

PROPERTIES

SKIN PROTECTANT

ANTI-INFLAMMATORY

PROMOTES SKIN HEALING

REMEDY FOR WOUNDS

INDICATIONS & USAGE SECTION

USES: TO RELIEVE SYMPTOMS ASSOCIATED WITH SKIN IRRITATIONS, ECZEMA, RASH, DRY SKIN, CUTS, BURNS, OPEN WOUNDS, AND MUCH MORE.

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS: APPLY TO AFFECTED AREA 3-4 TIMES PER DAY AS NEEDED. COVER WITH A BANDAID IF NECESSARY.

INACTIVE INGREDIENT SECTION

OTHER INGREDIENTS: ORGANIC EXTRA VIRGIN OLIVE OIL, HIGH OLEIC SAFFLOWER OIL, ORGANIC BEESWAX, CANADIAN BALSAM FIR.

WARNINGS SECTION

WARNING: TEST FOR ALLERGY BY RUBBING A SMALL AMOUNT ON SKIN FIRST. DO NOT USE IF ALLERGIC TO OR HYPER-SENSITIVE TO ANY INGREDIENT IN THIS SALVE. IF CONDITION PERSISTS OR WORSENS CONSULT YOUR HEALTH CARE PROVIDER.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN.

OTHER SAFETY INFORMATION

STORE IN A COOL DRY PLACE OR REFRIGERATE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

baby 1 ozbaby 1 oz

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52810-201-112023-01-30C16284748780-19855d018-d99d-cd31-e053-dbdaa90ab51aBABY SKIN SALVE (52810-201)
52810-201-112020-08-15C16284748780-19855d018-d99d-cd31-e053-dbdaa90ab51aBABY SKIN SALVE (52810-201)
52810-201-112019-11-27C16284748780-19855d018-d99d-cd31-e053-dbdaa90ab51aBABY SKIN SALVE (52810-201)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52810-201-11BABY SKIN30 mL in 1 JARSALVE304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52810-201BABY SKIN (PINE NEEDLE OIL, SAMBUCUS NIGRA FLOWER, CALENDULA OFFICINALIS FLOWER, ECHINACEA ANGUSTIFOLIA) SALVE [PUREMEDY]4Legacy NDC, 1 package rows20211221_60e0976f-4792-4a9c-9bfc-c2c3196f0e49.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CALENDULA OFFICINALIS FLOWERACTIVE INGREDIENTP0M7O4Y7YD1
ECHINACEA ANGUSTIFOLIAACTIVE INGREDIENTVB06AV5US81
PINE NEEDLE OIL (PINUS SYLVESTRIS)ACTIVE INGREDIENT5EXL5H740Y1
SAMBUCUS NIGRA FLOWERACTIVE INGREDIENT07V4DX094T1
CALENDULA OFFICINALIS FLOWERACTIVE MOIETYP0M7O4Y7YD1
ECHINACEA ANGUSTIFOLIAACTIVE MOIETYVB06AV5US81
PINE NEEDLE OIL (PINUS SYLVESTRIS)ACTIVE MOIETY5EXL5H740Y1
SAMBUCUS NIGRA FLOWERACTIVE MOIETY07V4DX094T1
ABIES BALSAMEA LEAF OILINACTIVE INGREDIENT2FGT9T2SQC1
OLIVE OILINACTIVE INGREDIENT6UYK2W1W1E1
SAFFLOWER OILINACTIVE INGREDIENT65UEH262IS1
YELLOW WAXINACTIVE INGREDIENT2ZA36H0S2V1

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52810-20152810-201-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
OLIVE OIL6UYK2W1W1EIACT
SAFFLOWER OIL65UEH262ISIACT
YELLOW WAX2ZA36H0S2VIACT
ABIES BALSAMEA LEAF OIL2FGT9T2SQCIACT
ECHINACEA ANGUSTIFOLIAVB06AV5US8ACTIB
SAMBUCUS NIGRA FLOWER07V4DX094TACTIB
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDACTIB
PINE NEEDLE OIL (PINUS SYLVESTRIS)5EXL5H740YACTIB

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 · 15 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
YELLOW WAXYELLOW WAX2ZA36H0S2VCAPSULE, EXTENDED RELEASE / ORAL80.67 mgExact identifier — unii candidate
9 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET, COATED / ORAL213.7 mgExact identifier — unii candidate
9 equally ranked IID candidates
SAFFLOWER OILSAFFLOWER OIL65UEH262ISLOTION / TOPICAL3510 mgExact identifier — unii candidate
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET / ORAL3.22 mgExact identifier — unii candidate
9 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VCAPSULE / ORAL44 mgExact identifier — unii candidate
9 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ECAPSULE / ORALNAExact identifier — unii candidate
5 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ESOLUTION / TOPICAL0.6 %w/wExact identifier — unii candidate
5 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET, EXTENDED RELEASE / ORAL0.01 mgExact identifier — unii candidate
9 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ESOLUTION / ORAL425 mg/1mlExact identifier — unii candidate
5 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET, DELAYED RELEASE / ORAL0.1 mgExact identifier — unii candidate
9 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ELOTION / TOPICAL32468 mgExact identifier — unii candidate
5 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ESOAP / TOPICALNAExact identifier — unii candidate
5 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET, SUGAR COATED / ORALNAExact identifier — unii candidate
9 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VOINTMENT / TOPICAL20 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VCREAM / TOPICAL5 %w/wExact 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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
cdb7762d-6dab-96b7-e053-2995a90a6dd260e0976f-4792-4a9c-9bfc-c2c3196f0e492021-10-06WarningsExact identifier
spl id: cdb7762d-6dab-96b7-e053-2995a90a6dd2
spl set id: 60e0976f-4792-4a9c-9bfc-c2c3196f0e49

Reported adverse events (FAERS/openFDA)#

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