ALL NATURAL WOUND AND BURN SPRAY (52810-219)

Manufacturer
PUREMEDY
Effective date
2024-01-11
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-06-01 02:25:34

Label at a glance#

ProductALL NATURAL WOUND AND BURN
Active ingredientCALENDULA OFFICINALIS FLOWER, ECHINACEA ANGUSTIFOLIA, SAMBUCUS NIGRA FLOWER
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS

CALENDULA OFFICINALIS (1X) HPUS (MARIGOLD)

ECHINACEA ANGUSTIFOLIA (1X) HPUS (ECHINACEA)

SAMBUCUS NIGRA (1X) HPUS (ELDERBERRY)

OTC - PURPOSE SECTION

PURPOSE

SWELLING, ITCHY SKIN, RED SPOTS WITH BURNING SENSATION

WOUND HEALING, SUPERFICIAL BURNS, SUNBURN AND SCALDS

DRY AND ITCHY SKIN, SKIN IRRITATION FROM INSECT BITES

INDICATIONS & USAGE SECTION

USES: TEMPORARITY RELIEVES SYMPTOMS ASSOCIATED WITH MINOR SKIN WOUNDS,

SUNBURN, SUPERFICIAL BURNS, SWELLING AND ITCHING. ALSO MAY BE USED TO CLEAN

WOUNDS. PRODUCT USES ARE BASED ON HOMEOPATHIC MATERIA MEDICA. THESE "USES"

HAVE NOT BEEN EVALUATED BY THE FDA.

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS: TEST FOR ALLERGY BY APPLYING A SMALL AMOUNT ON SKIN BEFORE USE.

APPLY TOPICALLY TO AFFECTED AREA 2-6 TIMES A DAY, OR AS DIRECTED BY YOUR PHYSICIAN.

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS: ORGANIC ALOE, ORGANIC OLIVE OIL (EXTRA VIRGIN), WILD HARVESTED PINE EXTRACT

WARNINGS SECTION

WARNING: 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

PRIOR REACTION TO THIS SALVE, STOP USE AND ASK A DOCTOR IF SYMPTOMS

PERSIST OR WORSEN. AVOID CONTACT WITH EYES.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN.

OTC - QUESTIONS SECTION

QUESTIONS OR COMMENTS: CALL 818-851-9014 BETWEEN8:AM - 5:PM PST

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Wound Burn Spray Label - 4 ozWound Burn Spray Label - 4 oz

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
52810-219-24ALL NATURAL WOUND AND BURN118 mL in 1 BOTTLESPRAY11810

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52810-219ALL NATURAL WOUND AND BURN (CALENDULA OFFICINALIS FLOWER, SAMBUCUS NIGRA FLOWER, ECHINACEA ANGUSTIFOLIA) SPRAY [PUREMEDY]10Legacy NDC, 1 package rows20240112_0b5bf195-0ec6-4860-aa2f-ccd6f3f394ee.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52810-21952810-219-24

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 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
0eb2e8d0-0969-79d6-e063-6294a90ab2740b5bf195-0ec6-4860-aa2f-ccd6f3f394ee2024-01-11WarningsExact identifier
spl id: 0eb2e8d0-0969-79d6-e063-6294a90ab274
spl set id: 0b5bf195-0ec6-4860-aa2f-ccd6f3f394ee

Reported adverse events (FAERS/openFDA)#

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