FDA.reportPublic FDA data

ACNE FREE

Manufacturer
PUREMEDY
Effective date
2024-01-11
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 02:25:35

Label at a glance#

ProductACNE FREE
Active ingredientECHINACEA ANGUSTIFOLIA, CALENDULA OFFICINALIS FLOWER, SAMBUCUS NIGRA FLOWER, MAHONIA AQUIFOLIUM FRUITING TOP
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS

ECHINACEA ANGUSTIFOLIA (2X) HPUS (ECHINACEA)

SAMBUCUS NIGRA (2X) HPUS (ELDERBERRY)

ORGANIC CALENDULA OFFICINALIS (2X) HPUS (MARIGOLD)

PINUS SILVESTRIS (1X) HPUS (PINE RESIN)

OTC - PURPOSE SECTION

PROPERTIES

ACNE TREATMENT

SKIN PROTECTANT

SKIN PROTECTANT

SKIN PROTECTANT

INDICATIONS & USAGE SECTION

USES: TO RELIEVE SYMPTOMS ASSOCIATED WITH ACNE

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS: APPLY LIBERALLY TO AFFECTED AREA 2-4 TIMES PER DAY OR AS NEEDED. MAY BE USED AS A FACE CREAM OR SPOT TREATMENT.

INACTIVE INGREDIENT SECTION

OTHER INGREDIENTS: ORGANIC EXTRA VIRGIN OLIVE OIL, ORGANIC SAFFLOWER OIL, ORGANIC BEESWAX, CANADIAN FIR BALSAM, ORGANIC TEA TREE 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.

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

acne 1 oz labelacne 1 oz label

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
52810-102-122025-07-29C16284748780-19855e2a2-4968-60a7-e053-dbdaa90a05bdACNE FREE (52810-102)
52810-102-122020-04-16C16284748780-19855e2a2-4968-60a7-e053-dbdaa90a05bdACNE FREE (52810-102)
52810-102-122019-11-27C16284748780-19855e2a2-4968-60a7-e053-dbdaa90a05bdACNE FREE (52810-102)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52810-102-12ACNE FREE60 mL in 1 JARSALVE608

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52810-102ACNE FREE (ECHINACEA ANGUSTIFOLIA, CALENDULA OFFICINALIS FLOWER, SAMBUCUS NIGRA FLOWER, MAHONIA AQUIFOLIUM FRUITING TOP) SALVE [PUREMEDY]8Legacy NDC, 1 package rows20240112_2e8de1d8-c881-42e6-8073-26fba52da0f6.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CALENDULA OFFICINALIS FLOWERACTIVE INGREDIENTP0M7O4Y7YD3
ECHINACEA ANGUSTIFOLIAACTIVE INGREDIENTVB06AV5US83
MAHONIA AQUIFOLIUM FRUITING TOPACTIVE INGREDIENTP119855ERN3
SAMBUCUS NIGRA FLOWERACTIVE INGREDIENT07V4DX094T3
CALENDULA OFFICINALIS FLOWERACTIVE MOIETYP0M7O4Y7YD3
ECHINACEA ANGUSTIFOLIAACTIVE MOIETYVB06AV5US83
MAHONIA AQUIFOLIUM FRUITING TOPACTIVE MOIETYP119855ERN3
SAMBUCUS NIGRA FLOWERACTIVE MOIETY07V4DX094T3
CANADA BALSAMINACTIVE INGREDIENTK304VI98I33
LAVANDULA ANGUSTIFOLIA FLOWERINACTIVE INGREDIENT19AH1RAF4M3
OLIVE OILINACTIVE INGREDIENT6UYK2W1W1E3
PINE NEEDLE OIL (PINUS SYLVESTRIS)INACTIVE INGREDIENT5EXL5H740Y3
SAFFLOWER OILINACTIVE INGREDIENT65UEH262IS3
TEA TREE OILINACTIVE INGREDIENTVIF565UC2G3
YELLOW WAXINACTIVE INGREDIENT2ZA36H0S2V3

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52810-10252810-102-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
OLIVE OIL6UYK2W1W1EIACT
SAFFLOWER OIL65UEH262ISIACT
YELLOW WAX2ZA36H0S2VIACT
PINE NEEDLE OIL (PINUS SYLVESTRIS)5EXL5H740YIACT
CANADA BALSAMK304VI98I3IACT
TEA TREE OILVIF565UC2GIACT
LAVANDULA ANGUSTIFOLIA FLOWER19AH1RAF4MIACT
ECHINACEA ANGUSTIFOLIAVB06AV5US8ACTIB
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDACTIB
SAMBUCUS NIGRA FLOWER07V4DX094TACTIB
MAHONIA AQUIFOLIUM FRUITING TOPP119855ERNACTIB

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 · 17 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
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
OLIVE OILOLIVE OIL6UYK2W1W1ESOLUTION / ORAL425 mg/1mlExact identifier — unii candidate
5 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VCAPSULE, EXTENDED RELEASE / ORAL80.67 mgExact identifier — unii candidate
9 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ELOTION / TOPICAL32468 mgExact identifier — unii candidate
5 equally ranked IID candidates
CANADA BALSAMCANADA BALSAMK304VI98I3LOTION / TOPICAL0.5 %w/wExact identifier — unii candidate
YELLOW WAXYELLOW WAX2ZA36H0S2VCREAM / TOPICAL5 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
PINE NEEDLE OIL (PINUS SYLVESTRIS)PINE NEEDLE OIL (PINUS SYLVESTRIS)5EXL5H740YLOTION / TOPICAL0.25 %w/wExact identifier — unii candidate
OLIVE OILOLIVE OIL6UYK2W1W1ESOAP / TOPICALNAExact 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 OIL6UYK2W1W1ECAPSULE / ORALNAExact identifier — unii candidate
5 equally ranked IID candidates
SAFFLOWER OILSAFFLOWER OIL65UEH262ISLOTION / TOPICAL3510 mgExact identifier — unii candidate
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET, COATED / ORAL213.7 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 WAX2ZA36H0S2VCAPSULE / ORAL44 mgExact identifier — unii candidate
9 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

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
0eb2cdb8-428b-509e-e063-6394a90a9f572e8de1d8-c881-42e6-8073-26fba52da0f62024-01-11WarningsExact identifier
spl id: 0eb2cdb8-428b-509e-e063-6394a90a9f57
spl set id: 2e8de1d8-c881-42e6-8073-26fba52da0f6

Reported adverse events (FAERS/openFDA)#

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