FDA.reportPublic FDA data

BLACK

Manufacturer
Natural Creations, Inc | OHM Pharma, Inc
Effective date
2018-12-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:13:09

Label at a glance#

ProductBLACK
Active ingredientECHINACEA ANGUSTIFOLIA WHOLE, GOLDENSEAL, PHYTOLACCA AMERICANA ROOT, PLANTAGO MAJOR WHOLE, STELLARIA MEDIA, COMFREY LEAF, TRIFOLIUM PRATENSE FLOWER, VERBASCUM THAPSUS WHOLE, ARSENIC TRIOXIDE, BUFO BUFO CUTANEOUS GLAND, LACHESIS MUTA VENOM, LYCOPODIUM CLAVATUM SPORE, SEPIA OFFICINALIS JUICE, SILICON DIOXIDE, THUJA OCCIDENTALIS LEAFY TWIG
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS: (HPUS*): Echinacea Ang 1X, Hydrastis 1X, Phytolacca 1X, Plantago 1X, Stellaria Med 1X, Symphytum 1X, Trifolium Prat 1X, Verbascum 1X, Arsenicum Alb 12X, Bufo 12X, Lachesis 12X, Lycopodium 12X, Sepia 12X, Silicea 12X, Thuja Occ 12X.

INDICATIONS & USAGE SECTION

USES: Temporarily relieves itching, burning, and redness, swelling of the skin, boils, hard nodular eruptions and/or warty growths.

OTC - PURPOSE SECTION

USES: Temporarily relieves itching, burning, and redness, swelling of the skin, boils, hard nodular eruptions and/or warty growths.

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS:  Apply a small amount to affected area or as directed by a health care professional.

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 right away.

WARNINGS SECTION

WARNINGS:

  • FOR TOPICAL USE ONLY.
  • 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.

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS: Carbomer 940, Glycerin, Organic Aloe Vera, Purified Water, Sodium Hydroxmethylglycinate.

OTC - QUESTIONS SECTION

QUESTIONS & COMMENTS?

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

REFERENCES SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 43406-0135-2

BLACK GEL

Warts*Skin Growths

TOPICAL HOMEOPATHIC GEL

 Net. Wt. 2oz. (56.7g)

image descriptionimage description

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
43406-0135-22022-01-28C16284748780-1d6a99b39-3e4b-a426-e053-dadaa90af4c2BLACK

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43406-0135-2BLACK56.7 g in 1 BOTTLE, PUMPGEL56.71

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43406-0135BLACK (ECHINACEA ANG., HYDRASTIS, PHYTOLACCA, PLANTAGO, STELLARIA MED., SYMPHYTUM, TRIFOLIUM PRAT., VERBASCUM, ARSENICUM ALB., BUFO, LACHESIS, LYCOPODIUM, SEPIA, SILICEA, THUJA OCC.) GEL [NATURAL CREATIONS, INC]1Legacy NDC, 1 package rows20200527_fc221651-5d94-46e9-966b-35918e8361fb.zip

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43406-013543406-0135-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
ECHINACEA ANGUSTIFOLIA WHOLEVB06AV5US8ACTIB
GOLDENSEALZW3Z11D0JVACTIB
PHYTOLACCA AMERICANA ROOT11E6VI8VEGACTIB
PLANTAGO MAJOR WHOLEW2469WNO6UACTIB
STELLARIA MEDIA2H03479QVRACTIB
COMFREY LEAFDG4F8T839XACTIB
TRIFOLIUM PRATENSE FLOWER4JS0838828ACTIB
VERBASCUM THAPSUS WHOLEC9TD27U172ACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
BUFO BUFO CUTANEOUS GLANDQ59QU6N72QACTIB
LACHESIS MUTA VENOMVSW71SS07IACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
SEPIA OFFICINALIS JUICEQDL83WN8C2ACTIB
SILICON DIOXIDEETJ7Z6XBU4ACTIB
THUJA OCCIDENTALIS LEAFY TWIG1NT28V9397ACTIB
CARBOMER 9404Q93RCW27EIACT
GLYCERINPDC6A3C0OXIACT
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
SODIUM HYDROXYMETHYLGLYCINATEDIG6BWZ9XTIACT

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
37c52945-f224-4eb5-ac99-dee1809d3edffc221651-5d94-46e9-966b-35918e8361fb2018-12-21WarningsExact identifier
spl id: 37c52945-f224-4eb5-ac99-dee1809d3edf
spl set id: fc221651-5d94-46e9-966b-35918e8361fb

Reported adverse events (FAERS/openFDA)#

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