FDA.reportPublic FDA data

ROSACEA FREE

Manufacturer
PUREMEDY
Effective date
2021-12-19
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:15:14

Label at a glance#

ProductROSACEA FREE
Active ingredientSAMBUCUS NIGRA FLOWER, CALENDULA OFFICINALIS FLOWER, PINE NEEDLE OIL (PINUS SYLVESTRIS), ABIES BALSAMEA LEAF OIL, ECHINACEA ANGUSTIFOLIA
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS

PINUS SILVESTRIS (1X) HPUS (PINE RESIN)

SAMBUCUS NIGRA (2X) HPUS (ELDERBERRY)

ORG. CALENDULA OFFICINALIS (2X) HPUS (MARIGOLD)

ABIES BALSAMEA (2X) HPUS (BALSAM FIR)

ECHINACEA ANGUSTIFOLIA (6X) HPUS

OTC - PURPOSE SECTION

PROPERTIES

SKIN PROTECTANT

ANTI-INFLAMMATORY

SKIN PROTECTANT

SKIN PROTECTANT

MULTI-PURPOSE SKIN HEALING REMEDY

INDICATIONS & USAGE SECTION

USES: TO RELIEVE SYMPTOMS ASSOCIATED WITH EXTREMELY DRY, DAMAGED, INFLAMED OR AGING SKIN.

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS: APPLY TO CLEAN, DRY AFFECTED AREA MORNING AND NIGHT, AS NEEDED UNTIL CONDITION CLEARS. THEN APPLY NIGHTLY TO MAINTAIN HEALTHY SKIN.

INACTIVE INGREDIENT SECTION

OTHER INGREDIENTS: ORGANIC BEESWAX, ORGANIC OLIVE OIL, ORGANIC ARGAN OIL, ORGANIC SEA BUCKTHORN OIL

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. (* = CERTIFIED ORGANIC INGREDIENTS)

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN.

OTC - QUESTIONS SECTION

CUSTOMER SERVICE 310-526-6108

OTHER SAFETY INFORMATION

STORE IN A COOL DRY PLACE OR REFRIGERATE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

rosacea 1 ozrosacea 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
52810-602-112023-01-30C16284748780-19855d018-e237-cd31-e053-dbdaa90ab51aROSACEA FREE (52810-602)
52810-602-112020-05-21C16284748780-19855d018-e237-cd31-e053-dbdaa90ab51aROSACEA FREE (52810-602)
52810-602-112019-11-27C16284748780-19855d018-e237-cd31-e053-dbdaa90ab51aROSACEA FREE (52810-602)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52810-602-11ROSACEA FREE30 mL in 1 JARSALVE304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52810-602ROSACEA FREE (PINE NEEDLE OIL (PINUS SYLVESTRIS) SAMBUCUS NIGRA FLOWER CALENDULA OFFICINALIS FLOWER ABIES BALSAMEA LEAF OIL ECHINACEA ANGUSTIFOLIA) SALVE [PUREMEDY]4Legacy NDC, 1 package rows20211221_12c6bff2-cf77-4d81-b0d8-a3583a35aac2.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ABIES BALSAMEA LEAF OILACTIVE INGREDIENT2FGT9T2SQC1
CALENDULA OFFICINALIS FLOWERACTIVE INGREDIENTP0M7O4Y7YD1
ECHINACEA ANGUSTIFOLIAACTIVE INGREDIENTVB06AV5US81
PINE NEEDLE OIL (PINUS SYLVESTRIS)ACTIVE INGREDIENT5EXL5H740Y1
SAMBUCUS NIGRA FLOWERACTIVE INGREDIENT07V4DX094T1
ABIES BALSAMEA LEAF OILACTIVE MOIETY2FGT9T2SQC1
CALENDULA OFFICINALIS FLOWERACTIVE MOIETYP0M7O4Y7YD1
ECHINACEA ANGUSTIFOLIAACTIVE MOIETYVB06AV5US81
PINE NEEDLE OIL (PINUS SYLVESTRIS)ACTIVE MOIETY5EXL5H740Y1
SAMBUCUS NIGRA FLOWERACTIVE MOIETY07V4DX094T1
ARGAN OILINACTIVE INGREDIENT4V59G5UW9X1
HIPPOPHAE RHAMNOIDES WHOLEINACTIVE INGREDIENTYAA7TG74X61
OLIVE OILINACTIVE INGREDIENT6UYK2W1W1E1
YELLOW WAXINACTIVE INGREDIENT2ZA36H0S2V1

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52810-60252810-602-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
OLIVE OIL6UYK2W1W1EIACT
ARGAN OIL4V59G5UW9XIACT
YELLOW WAX2ZA36H0S2VIACT
HIPPOPHAE RHAMNOIDES WHOLEYAA7TG74X6IACT
SAMBUCUS NIGRA FLOWER07V4DX094TACTIB
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDACTIB
PINE NEEDLE OIL (PINUS SYLVESTRIS)5EXL5H740YACTIB
ABIES BALSAMEA LEAF OIL2FGT9T2SQCACTIB
ECHINACEA ANGUSTIFOLIAVB06AV5US8ACTIB

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 · 14 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
OLIVE OILOLIVE OIL6UYK2W1W1ELOTION / TOPICAL32468 mgExact identifier — unii candidate
5 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ESOLUTION / ORAL425 mg/1mlExact identifier — unii candidate
5 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ESOLUTION / TOPICAL0.6 %w/wExact identifier — unii candidate
5 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ECAPSULE / ORALNAExact identifier — unii candidate
5 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ESOAP / TOPICALNAExact identifier — unii candidate
5 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET, COATED / ORAL213.7 mgExact identifier — unii candidate
9 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET, EXTENDED RELEASE / ORAL0.01 mgExact identifier — unii candidate
9 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VCAPSULE / ORAL44 mgExact identifier — unii candidate
9 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VCREAM / TOPICAL5 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VCAPSULE, EXTENDED RELEASE / ORAL80.67 mgExact identifier — unii candidate
9 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET / ORAL3.22 mgExact identifier — unii candidate
9 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VOINTMENT / TOPICAL20 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET, SUGAR COATED / ORALNAExact identifier — unii candidate
9 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET, DELAYED RELEASE / ORAL0.1 mgExact 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
d3879bdc-5919-dcee-e053-2995a90ad9cd12c6bff2-cf77-4d81-b0d8-a3583a35aac22021-12-19WarningsExact identifier
spl id: d3879bdc-5919-dcee-e053-2995a90ad9cd
spl set id: 12c6bff2-cf77-4d81-b0d8-a3583a35aac2