FDA.reportPublic FDA data

ECZEMA HP

Manufacturer
Natural Creations, Inc. | OHM Pharma, Inc.
Effective date
2023-01-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:19:40

Label at a glance#

ProductECZEMA HP
Active ingredientARSENIC TRIOXIDE, OYSTER SHELL CALCIUM CARBONATE, CRUDE, GRAPHITE, MERCURIUS SOLUBILIS, DAPHNE MEZEREUM BARK, TOXICODENDRON PUBESCENS LEAF, SEPIA OFFICINALIS JUICE, SULFUR
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS (HPUS*) - equal amounts of: Arsenicum Album 30X, Calcarea Carbonica 30X, Graphites 30X, Mercurius Solubilis 30X, Mezereum 30X, Rhus Toxicodendron 30X, Sepia 30X, Sulphur 30X

INDICATIONS & USAGE SECTION

USES: Temporarily relieves minor skin irritation due to eczema.**

WARNINGS SECTION

WARNING:

  • Consult a physician for use in children under 12 years of age. 
  • IF PREGNANT OR BREAST-FEEDING, ask a health care professional before use. 
  • KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.
  • Do not use if TAMPER EVIDENT seal is broken or missing.

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS: Adults and children above 12 years: 10 drops orally 3 times daily, or as directed by a health care professional.

REFERENCES SECTION

*The letters "HPUS" indicate the components in the product are officially monographed in the Homeopathic Pharmacopeia of the United States.

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS: Purified Water, USP Ethanol Alcohol 20%

OTC - QUESTIONS SECTION

QUESTIONS AND COMMENTS?

Natural Creations / Woodbine, IA 51579 / 712-647-1600

OTC - PURPOSE SECTION

USES: Temporarily relieves minor skin irritation due to eczema.**

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 43406-0019-1

ECZEMA HP

HOMEOPATHIC

1 fl oz (3o mL) / 20% Alcohol

Image Of LabelImage Of Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43406-0019-12023-01-19C16284748780-19855d018-e1cb-cd31-e053-dbdaa90ab51aECZEMA HP
43406-0019-12019-11-27C16284748780-19855d018-e1cb-cd31-e053-dbdaa90ab51aECZEMA HP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43406-0019-1ECZEMA HP30 mL in 1 BOTTLE, DROPPERLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43406-0019ECZEMA HP (ARSENIC TRIOXIDE 30X, OYSTER SHELL CALCIUM CARBONATE, CRUDE 30X, GRAPHITE 30X, MERCURIUS SOLUBILIS 30X, DAPHNE MEZEREUM BARK 30X, TOXICODENDRON PUBESCENS LEAF 30X, SEPIA OFFICINALIS JUICE 30X, SULFUR 30X) LIQUID [NATURAL CREATIONS, INC.]2Current NDC, Legacy NDC, 1 package rows20230120_725d40fe-e9e4-40ff-8b18-5bd5c3e356f8.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ARSENIC TRIOXIDEACTIVE INGREDIENTS7V92P67HO1
DAPHNE MEZEREUM BARKACTIVE INGREDIENTX2N6E405GV1
GRAPHITEACTIVE INGREDIENT4QQN74LH4O1
MERCURIUS SOLUBILISACTIVE INGREDIENT324Y4038G21
OYSTER SHELL CALCIUM CARBONATE, CRUDEACTIVE INGREDIENT2E32821G6I1
SEPIA OFFICINALIS JUICEACTIVE INGREDIENTQDL83WN8C21
SULFURACTIVE INGREDIENT70FD1KFU701
TOXICODENDRON PUBESCENS LEAFACTIVE INGREDIENT6IO182RP7A1
ARSENIC CATION (3+)ACTIVE MOIETYC96613F5AV1
DAPHNE MEZEREUM BARKACTIVE MOIETYX2N6E405GV1
GRAPHITEACTIVE MOIETY4QQN74LH4O1
MERCURIC CATIONACTIVE MOIETYED30FJ8Y421
OYSTER SHELL CALCIUM CARBONATE, CRUDEACTIVE MOIETY2E32821G6I1
SEPIA OFFICINALIS JUICEACTIVE MOIETYQDL83WN8C21
SULFURACTIVE MOIETY70FD1KFU701
TOXICODENDRON PUBESCENS LEAFACTIVE MOIETY6IO182RP7A1
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43406-001943406-0019-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
ARSENIC TRIOXIDES7V92P67HOACTIB
OYSTER SHELL CALCIUM CARBONATE, CRUDE2E32821G6IACTIB
GRAPHITE4QQN74LH4OACTIB
MERCURIUS SOLUBILIS324Y4038G2ACTIB
DAPHNE MEZEREUM BARKX2N6E405GVACTIB
TOXICODENDRON PUBESCENS LEAF6IO182RP7AACTIB
SEPIA OFFICINALIS JUICEQDL83WN8C2ACTIB
SULFUR70FD1KFU70ACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

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 · 2 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route+dosage form
2 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
ECZEMA HPARSENIC TRIOXIDE 30X, OYSTER SHELL CALCIUM CARBONATE, CRUDE 30X, GRAPHITE 30X, MERCURIUS SOLUBILIS 30X, DAPHNE MEZEREUM BARK 30X, TOXICODENDRON PUBESCENS LEAF 30X, SEPIA OFFICINALIS JUICE 30X, SULFUR 30XNatural Creations, Inc.725d40fe-e9e4-40ff-8b18-5bd5c3e356f82023-01-05WarningsExact identifier
ndc (package): 43406-0019-1
ndc (product): 43406-0019
ndc11 (package): 43406001901
spl id: 899a9516-b5ed-40d2-a044-a2cb4ddbc91a
spl set id: 725d40fe-e9e4-40ff-8b18-5bd5c3e356f8

Reported adverse events (FAERS/openFDA)#

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