FDA.reportPublic FDA data

DERMATOME STAT

Manufacturer
Energique, Inc. | Apotheca Company
Effective date
2024-08-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:27:49

Label at a glance#

ProductDERMATOME STAT
Active ingredientASTRAGALUS PROPINQUUS ROOT, ECHINACEA ANGUSTIFOLIA WHOLE, HYPERICUM PERFORATUM WHOLE, GOLDENSEAL, SOLANUM DULCAMARA TOP, GELSEMIUM SEMPERVIRENS ROOT, NITRIC ACID, RANUNCULUS BULBOSUS WHOLE, THUJA OCCIDENTALIS LEAFY TWIG
Label structure9 sections

Indications and uses

May temporarily relieve symptoms associated with infections: • aches • pains • febrile conditions • painful skin lesions** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Dosage and administration

• Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. • Consult a physician for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

(in each drop): Dulcamara 12X 16.62%, Gelsemium Sempervirens 12X 16.62%, Hydrastis Canadensis 6X 16.62%, Nitricum Acidum 12X 16.62%, Ranunculus Bulbosus 12X 16.62%, Thuja Occidentalis 12X 16.62%, Astragalus Membranaceus 3X 0.10%, Echinacea (Angustifolia) 3X 0.10%, Hypericum Perforatum 3X 0.10%.

PURPOSE:

OTC - PURPOSE SECTION

Dulcamara - itching,** Gelsemium Sempervirens - redness,** Hydrastis Canadensis – burning pain,** Nitricum Acidum – stitching pain,** Ranunculus Bulbosus – stinging pain,** Thuja Occidentalis – tingling,** Astragalus Membranaceus - fatigue,** Echinacea - rash,** Hypericum Perforatum – sensitive skin**

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

USES:

INDICATIONS & USAGE SECTION

May temporarily relieve symptoms associated with infections:

• aches • pains • febrile conditions • painful skin lesions**

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

WARNINGS:

WARNINGS SECTION

Stop use and ask a doctor if symptoms persist for more than 3 days.

If pregnant or breastfeeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DO NOT UE IF TAMPER EVIDENT SEAL IS BROKEN OR MISSING

Store in a cool, dry place.

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

• Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional.

• Consult a physician for use in children under 12 years of age.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Demineralized water, 20% Ethanol.

QUESTIONS:

OTC - QUESTIONS SECTION

Dist. by Energique, Inc.
201 Apple Blvd.
Woodbine, IA 51579

800.869.8078

PACKAGE LABLE DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

DERMATOME STAT

1 fl. oz. (30 ml)

DERMATOME STATDERMATOME STAT

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
44911-0570-12024-08-20C16284748780-1f386c64a-0417-0266-e053-dadaa90a7c1aDRUG FACTS:
44911-0570-12023-01-30C16284748780-1f386c64a-0417-0266-e053-dadaa90a7c1aDRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44911-0570-1DERMATOME STAT30 mL in 1 BOTTLE, DROPPERLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44911-0570DERMATOME STAT (ASTRAGALUS MEMBRANACEUS, ECHINACEA (ANGUSTIFOLIA), HYPERICUM PERFORATUM, HYDRASTIS CANADENSIS, DULCAMARA, GELSEMIUM SEMPERVIRENS, NITRICUM ACIDUM, RANUNCULUS BULBOSUS, THUJA OCCIDENTALIS) LIQUID [ENERGIQUE, INC.]2Current NDC, Legacy NDC, 1 package rows20240822_6e48c2a9-f08a-418f-9b25-03a2010c340f.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
44911-057044911-0570-1

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
ASTRAGALUS PROPINQUUS ROOT922OP8YUPFACTIB
ECHINACEA ANGUSTIFOLIA WHOLEVB06AV5US8ACTIB
HYPERICUM PERFORATUM WHOLEXK4IUX8MNBACTIB
GOLDENSEALZW3Z11D0JVACTIB
SOLANUM DULCAMARA TOPKPS1B1162NACTIB
GELSEMIUM SEMPERVIRENS ROOT639KR60Q1QACTIB
NITRIC ACID411VRN1TV4ACTIB
RANUNCULUS BULBOSUS WHOLEAEQ8NXJ0MBACTIB
THUJA OCCIDENTALIS LEAFY TWIG1NT28V9397ACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

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
DERMATOME STATASTRAGALUS MEMBRANACEUS, ECHINACEA (ANGUSTIFOLIA), HYPERICUM PERFORATUM, HYDRASTIS CANADENSIS, DULCAMARA, GELSEMIUM SEMPERVIRENS, NITRICUM ACIDUM, RANUNCULUS BULBOSUS, THUJA OCCIDENTALISEnergique, Inc.6e48c2a9-f08a-418f-9b25-03a2010c340f2024-08-20WarningsExact identifier
ndc (package): 44911-0570-1
ndc (product): 44911-0570
ndc11 (package): 44911057001
spl id: 4bc06485-b85c-4da9-bc84-abf77bc23f18
spl set id: 6e48c2a9-f08a-418f-9b25-03a2010c340f

Reported adverse events (FAERS/openFDA)#

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