FDA.reportPublic FDA data

RASH RELIEF

Manufacturer
PUREMEDY
Effective date
2024-01-11
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 02:25:37

Label at a glance#

ProductRASH RELIEF
Active ingredientCALENDULA OFFICINALIS FLOWER, SAMBUCUS NIGRA FLOWER, ARNICA MONTANA
Label structure9 sections

Indications and uses

TEMPORARILY RELIEVES SYMPTOMS COMMONLY ASSOCUATED WITH RASHES. PRODUCT USES ARE BASED ON HOMEOPATHIS MATERIA MEDICA. THESE 'USES' HAVE NOT BEEN EVALUATED BY THE FOOD AND DRUG ADMINISTRATION. THIS PRODUCT HAS NOT 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.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

EACH DOSE CONTAINS EQUAL PARTS OF

ARNICA MONTANA 1X HPUS (ARNIC)

cALENDULA OFFICINALIS 1X HPUS (MARIGOLD)

SAMBUCUS NIGRA 1 X (ELDERBERRY)

PURPOSE

OTC - PURPOSE SECTION

ITCHY AND BURNING SKIN

WOUND HEALING

SWELLING, RED BURING SPOTS ON CHEEKS

USES

INDICATIONS & USAGE SECTION

TEMPORARILY RELIEVES SYMPTOMS COMMONLY ASSOCUATED WITH RASHES. PRODUCT USES ARE BASED ON HOMEOPATHIS MATERIA MEDICA. THESE 'USES' HAVE NOT BEEN EVALUATED BY THE FOOD AND DRUG ADMINISTRATION. THIS PRODUCT HAS NOT 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.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

CASTOR OIL, HYDROGENATED CASTOR OIL WAX, EXTRA VIRGIN OLIVE OIL

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 PERSISTS OR WORSEN. AVOID  CONTACT WITH EYES.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP ALL DRUGS OUT OF REACH OF CHILDREN.

QUESTIONS OR COMMENTS?

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RashRelief_1oz_2015RashRelief_1oz_2015

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
52810-218-112025-07-29C16284748780-19d75b9cf-edbf-f424-e053-dadaa90a57ceRASH RELIEF (52810-218)
52810-218-112020-04-20C16284748780-19d75b9cf-edbf-f424-e053-dadaa90a57ceRASH RELIEF (52810-218)
52810-218-112020-01-31C16284748780-19d75b9cf-edbf-f424-e053-dadaa90a57ceRASH RELIEF (52810-218)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52810-218-11RASH RELIEF30 mL in 1 JARSALVE305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52810-218RASH RELIEF (ARNICA MONTANA, CALENDULA OFFICINALIS, SAMBUCUS NIGRA) SALVE [PUREMEDY]5Legacy NDC, 1 package rows20240112_c58b223d-c7fc-44ad-aa28-8eabd15797e2.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ARNICA MONTANAACTIVE INGREDIENTO80TY208ZW1
CALENDULA OFFICINALIS FLOWERACTIVE INGREDIENTP0M7O4Y7YD1
SAMBUCUS NIGRA FLOWERACTIVE INGREDIENT07V4DX094T1
ARNICA MONTANAACTIVE MOIETYO80TY208ZW1
CALENDULA OFFICINALIS FLOWERACTIVE MOIETYP0M7O4Y7YD1
SAMBUCUS NIGRA FLOWERACTIVE MOIETY07V4DX094T1
CASTOR OILINACTIVE INGREDIENTD5340Y2I9G1
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEY1
OLIVE OILINACTIVE INGREDIENT6UYK2W1W1E1

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
52810-21852810-218-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
OLIVE OIL6UYK2W1W1EIACT
CASTOR OILD5340Y2I9GIACT
HYDROGENATED CASTOR OILZF94AP8MEYIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDACTIB
SAMBUCUS NIGRA FLOWER07V4DX094TACTIB
ARNICA MONTANAO80TY208ZWACTIB

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 · 33 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CASTOR OILCASTOR OILD5340Y2I9GEMULSION / OPHTHALMIC32 mgExact identifier — unii candidate
16 equally ranked IID candidates
HYDROGENATED CASTOR OILHYDROGENATED CASTOR OILZF94AP8MEYAEROSOL, FOAM / TOPICAL2 %w/wExact identifier — unii candidate
12 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GCAPSULE, EXTENDED RELEASE / ORAL47 mgExact identifier — unii candidate
16 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GTABLET, COATED / ORAL0.9 mgExact identifier — unii candidate
16 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GTABLET, FILM COATED / ORAL15.29 mgExact identifier — unii candidate
16 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GTABLET / SUBLINGUAL1.6 mgExact identifier — unii candidate
16 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GTABLET / ORAL17 mgExact identifier — unii candidate
16 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ELOTION / TOPICAL32468 mgExact identifier — unii candidate
5 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GGRANULE, FOR SUSPENSION / ORAL128 mgExact identifier — unii candidate
16 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GINJECTION / INTRAMUSCULAR885 mgExact identifier — unii candidate
16 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GSPRAY / NASALNAExact identifier — unii candidate
16 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GINJECTION, SOLUTION / INTRAMUSCULAR525 mgExact identifier — unii candidate
16 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ECAPSULE / ORALNAExact identifier — unii candidate
5 equally ranked IID candidates
HYDROGENATED CASTOR OILHYDROGENATED CASTOR OILZF94AP8MEYCAPSULE, DELAYED RELEASE / ORAL3.1 mgExact identifier — unii candidate
12 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ESOLUTION / TOPICAL0.6 %w/wExact identifier — unii candidate
5 equally ranked IID candidates
HYDROGENATED CASTOR OILHYDROGENATED CASTOR OILZF94AP8MEYTABLET, DELAYED RELEASE / ORAL1337 mgExact identifier — unii candidate
12 equally ranked IID candidates
HYDROGENATED CASTOR OILHYDROGENATED CASTOR OILZF94AP8MEYCAPSULE / ORAL405 mgExact identifier — unii candidate
12 equally ranked IID candidates
HYDROGENATED CASTOR OILHYDROGENATED CASTOR OILZF94AP8MEYTABLET, EXTENDED RELEASE / ORAL393 mgExact identifier — unii candidate
12 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GTABLET, EXTENDED RELEASE / ORAL23.27 mgExact identifier — unii candidate
16 equally ranked IID candidates
HYDROGENATED CASTOR OILHYDROGENATED CASTOR OILZF94AP8MEYTABLET, FOR SUSPENSION / ORAL17 mgExact identifier — unii candidate
12 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GOINTMENT / TOPICAL14.9 %w/wExact identifier — unii candidate
16 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GTABLET, DELAYED RELEASE / ORAL0.01 mgExact identifier — unii candidate
16 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GSOLUTION / TOPICAL1.38 %w/wExact identifier — unii candidate
16 equally ranked IID candidates
HYDROGENATED CASTOR OILHYDROGENATED CASTOR OILZF94AP8MEYCAPSULE, EXTENDED RELEASE / ORAL410.82 mgExact identifier — unii candidate
12 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ESOAP / TOPICALNAExact identifier — unii candidate
5 equally ranked IID candidates
HYDROGENATED CASTOR OILHYDROGENATED CASTOR OILZF94AP8MEYTABLET, FILM COATED / ORAL17 mgExact identifier — unii candidate
12 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ESOLUTION / ORAL425 mg/1mlExact identifier — unii candidate
5 equally ranked IID candidates
HYDROGENATED CASTOR OILHYDROGENATED CASTOR OILZF94AP8MEYSUSPENSION / TOPICAL286 mgExact identifier — unii candidate
12 equally ranked IID candidates
HYDROGENATED CASTOR OILHYDROGENATED CASTOR OILZF94AP8MEYLIQUID / TOPICAL0.24 %w/wExact identifier — unii candidate
12 equally ranked IID candidates
HYDROGENATED CASTOR OILHYDROGENATED CASTOR OILZF94AP8MEYTABLET / SUBLINGUAL1.6 mgExact identifier — unii candidate
12 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GCAPSULE / ORAL1.04 mgExact identifier — unii candidate
16 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GGEL / NASAL429 mgExact identifier — unii candidate
16 equally ranked IID candidates
HYDROGENATED CASTOR OILHYDROGENATED CASTOR OILZF94AP8MEYTABLET / ORAL232 mgExact identifier — unii candidate
12 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
0eb2e9eb-7b92-57f5-e063-6394a90aa795c58b223d-c7fc-44ad-aa28-8eabd15797e22024-01-11WarningsExact identifier
spl id: 0eb2e9eb-7b92-57f5-e063-6394a90aa795
spl set id: c58b223d-c7fc-44ad-aa28-8eabd15797e2

Reported adverse events (FAERS/openFDA)#

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