FDA.reportPublic FDA data

HaloDerm Regular

Manufacturer
Haloderm, Inc. | Apotheca Company
Effective date
2022-05-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:01:50

Label at a glance#

ProductHaloDerm Regular
Active ingredientSOLANUM DULCAMARA TOP, NITRIC ACID, THUJA OCCIDENTALIS LEAFY TWIG, ANTIMONY TRISULFIDE, OYSTER SHELL CALCIUM CARBONATE, CRUDE, SILICON DIOXIDE
Label structure9 sections

Dosage and administration

Adults & Children 13 years & over - Apply only enough to coat the entire blemish. For first use leave on for 45 minutes and cover with bandage. If a second coat is needed, leave on over night. Repeat if necessary.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Dulcamara 10X, Nitricum Acidum 10X, Thuja Occidentalis 10X, Antimonium Crudum 12X, Calcarea Carbonica 12X, Silicea 12X.

INDICATIONS:

OTC - PURPOSE SECTION

Homeopathic formula to target benign mole and skin tag symptoms.

WARNINGS:

WARNINGS SECTION

For External Use only: Keep out of eyes and away from mucous membranes

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Adults & Children 13 years & over - Apply only enough to coat the entire blemish. For first use leave on for 45 minutes and cover with bandage. If a second coat is needed, leave on over night. Repeat if necessary.

INDICATIONS:

INDICATIONS & USAGE SECTION

Homeopathic formula to target benign mole and skin tag symptoms.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Demineralized Water, Bloodroot (Root) Sanguinaria Canadensis Powder, Glycerin, Zinc Chloride, Bloodroot (Root) Sanguinaria Canadensis Extract, PEG-33, PEG-8 Dimethicone, PEG-14, Propylene Glycol, Diazolidinyl Urea, Iodopropynyl Butylcarbamate.

QUESTIONS:

OTC - QUESTIONS SECTION

HaloDerm Inc, Carlsbad, CA 92011

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HaloDerm
homeopathic mole & skin tag remover
.17 oz (5g)
REGULAR

HaloDerm RegularHaloDerm Regular

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71950-000271950-0002-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
SOLANUM DULCAMARA TOPKPS1B1162NACTIB
NITRIC ACID411VRN1TV4ACTIB
THUJA OCCIDENTALIS LEAFY TWIG1NT28V9397ACTIB
ANTIMONY TRISULFIDEF79059A38UACTIB
OYSTER SHELL CALCIUM CARBONATE, CRUDE2E32821G6IACTIB
SILICON DIOXIDEETJ7Z6XBU4ACTIB
WATER059QF0KO0RIACT
SANGUINARIA CANADENSIS ROOTN9288CD508IACT
GLYCERINPDC6A3C0OXIACT
ZINC CHLORIDE86Q357L16BIACT
POLYETHYLENE GLYCOL 15001212Z7S33AIACT
PEG-8 DIMETHICONEGIA7T764ODIACT
POLYETHYLENE GLYCOL 700762678AC5RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
IODOPROPYNYL BUTYLCARBAMATE603P14DHEBIACT

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
c52aadf3-c483-4a57-8ce0-263dfceeac91a2d372e5-73d5-479c-b781-7aed282dcbca2022-05-06WarningsExact identifier
spl id: c52aadf3-c483-4a57-8ce0-263dfceeac91
spl set id: a2d372e5-73d5-479c-b781-7aed282dcbca

Reported adverse events (FAERS/openFDA)#

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