EXTRA DRAWING ACNE RELIEF

Manufacturer
PUREMEDY
Effective date
2024-01-11
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 02:25:36

Label at a glance#

ProductEXTRA DRAWING ACNE RELIEF
Active ingredientMAHONIA AQUIFOLIUM FRUITING TOP, CALENDULA OFFICINALIS FLOWER, ECHINACEA ANGUSTIFOLIA, SAMBUCUS NIGRA FLOWER, THUJA OCCIDENTALIS LEAF
Label structure9 sections

Indications and uses

TEMPORARILY RELIEVES SYMPTOMS SUCH AS RED SPOTS, PUSTULES, BURNING AND OTHER IRRITATIONS ASSOCIATED WITH ACNE. PRODUCT USES ARE BASED ON HOMEOPATHIC MATERIA MEDICA. THESE 'USES' HAVE NOT BEEN EVALUATED BY THE FOOD AND DRUG ADMINISTRATION. THIS PRODUCT HAS NOT YET BEEN CLINICALLY TESTED BY PUREMEDY INC.

Dosage and administration

TEST FOR ALLERGY BY RUBBING A SMALL AMOUNT ON SKIN BEFORE USE. APPLY TOPICALLY TO AFFECTED AREA 2-3 TIMES A DAY, OR AS DIRECTED BY YOUR PHYSICIAN OR HEALTH CARE PRACTITIONER.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

ORGANIC BERBERIS AQUIFOLIUM (1X) HPUS (MOUNTAIN GRAPE)

ORGANIC CALENDULA OFFICINALIS (1X) HPUS (MARIGOLD)

ORGANIC ECHINACEA ANGUSTIFOLIA (1X) HPUS (ECHINACEA)

ORGANIC SAMBUCUS NIGRA (1X) HPUS (ELDERBERRY)

ORGANIC THUJA OCCIDENTALIS (1X) HPUS (ARBOR VITAE)

PURPOSE

OTC - PURPOSE SECTION

ACNE

WOUND HEALING

SMALL RED PIMPLES ON NECK AND FACE

SWELLING, RED SPOTS BURNING

ACNE

USES

INDICATIONS & USAGE SECTION

TEMPORARILY RELIEVES SYMPTOMS SUCH AS RED SPOTS, PUSTULES, BURNING AND OTHER IRRITATIONS ASSOCIATED WITH ACNE. PRODUCT USES ARE BASED ON HOMEOPATHIC MATERIA MEDICA. THESE 'USES' HAVE NOT BEEN EVALUATED BY THE FOOD AND DRUG ADMINISTRATION. THIS PRODUCT HAS NOT YET BEEN CLINICALLY TESTED BY PUREMEDY INC.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

TEST FOR ALLERGY BY RUBBING A SMALL AMOUNT ON SKIN BEFORE USE. APPLY TOPICALLY TO AFFECTED AREA 2-3 TIMES A DAY, OR AS DIRECTED BY YOUR PHYSICIAN OR HEALTH CARE PRACTITIONER.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

BEESWAX*, BLOODROOT, CANADIAN FIR BALSAM**, LAVENDER OIL*, OLIVE OIL*, PINE EXTRACT**

*ORGANIC **WILD HARVESTED

WARNINGS

WARNINGS SECTION

FOR EXTERNAL USE ONLY. DO NOT USE IF YOU HAVE AN ALLERGY OR HYPERSENSITIVITY TO THE COMPONENTS OF THE FORMULA OR IF YOU HAVE HAD A PRIOR REACTION TO THIS SALVE. STOP USE AND ASK A DOCTOR IF SYMPTOMS PERSIST OR WORSEN. AVOID CONTACT WITH EYES.

KEEP OUT OF REACH OF CHILDREN. 

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

IF SWALLOWED CONTACT A HEALTH CARE PROVIDER OR POISON CONTROL CENTER RIGHT AWAY.

QUESTIONS OR COMMENTS?

OTC - QUESTIONS SECTION

CALL 818-851-9014 BETWEEN 8:AM AND 5:PM PST 

*SEE BOX FOR FULL INFORMATION.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CS5_Acne_extradrawing 1oz.jpgCS5_Acne_extradrawing 1oz.jpg

CS5_Acne_extradrawing 2 oz.jpgCS5_Acne_extradrawing 2 oz.jpg

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52810-103-12EXTRA DRAWING ACNE RELIEF28 g in 1 JARSALVE285
52810-103-13EXTRA DRAWING ACNE RELIEF56 g in 1 JARSALVE565

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52810-103EXTRA DRAWING ACNE RELIEF (MAHONIA AQUIFOLIUM, CALENDULA OFFICINALIS, ECHINACEA ANGUSTIFOLIA, SAMBUCUS NIGRA, THUJA OCCIDENTALIS) SALVE [PUREMEDY]5Legacy NDC, 2 package rows20240112_3e8dfa74-8e63-41e4-a4d3-c6cfa805b215.zip

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
52810-10352810-103-12, 52810-103-13

Ingredients#

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

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

Source Document#

Source XML

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
0eb2c0fe-dc54-4b76-e063-6394a90a5e763e8dfa74-8e63-41e4-a4d3-c6cfa805b2152024-01-11WarningsExact identifier
spl id: 0eb2c0fe-dc54-4b76-e063-6394a90a5e76
spl set id: 3e8dfa74-8e63-41e4-a4d3-c6cfa805b215

Reported adverse events (FAERS/openFDA)#

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