HALODERM REGULAR- dulcamara, nitricum acidum, thuja occidentalis, antimonium crudum, calcarea carbonica, silicea paste

HaloDerm Regular by

Drug Labeling and Warnings

HaloDerm Regular by is a Homeopathic medication manufactured, distributed, or labeled by Haloderm, Inc., Apotheca Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS:

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

INDICATIONS:

Homeopathic formula to target benign mole and skin tag symptoms.

WARNINGS:

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

KEEP OUT OF REACH OF CHILDREN:

Keep out of reach of children.

DIRECTIONS:

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:

Homeopathic formula to target benign mole and skin tag symptoms.

INACTIVE INGREDIENTS:

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:

HaloDerm Inc, Carlsbad, CA 92011

PACKAGE LABEL DISPLAY:

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

INGREDIENTS AND APPEARANCE

HALODERM REGULAR 
dulcamara, nitricum acidum, thuja occidentalis, antimonium crudum, calcarea carbonica, silicea paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71950-0002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SOLANUM DULCAMARA TOP (UNII: KPS1B1162N) (SOLANUM DULCAMARA TOP - UNII:KPS1B1162N)	SOLANUM DULCAMARA TOP	10 [hp_X]  in 1 g
NITRIC ACID (UNII: 411VRN1TV4) (NITRIC ACID - UNII:411VRN1TV4)	NITRIC ACID	10 [hp_X]  in 1 g
THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397)	THUJA OCCIDENTALIS LEAFY TWIG	10 [hp_X]  in 1 g
ANTIMONY TRISULFIDE (UNII: F79059A38U) (ANTIMONY TRISULFIDE - UNII:F79059A38U)	ANTIMONY TRISULFIDE	12 [hp_X]  in 1 g
OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I)	OYSTER SHELL CALCIUM CARBONATE, CRUDE	12 [hp_X]  in 1 g
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	12 [hp_X]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508)
GLYCERIN (UNII: PDC6A3C0OX)
ZINC CHLORIDE (UNII: 86Q357L16B)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
PEG-8 DIMETHICONE (UNII: GIA7T764OD)
POLYETHYLENE GLYCOL 700 (UNII: 762678AC5R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71950-0002-1	5 g in 1 TUBE; Type 0: Not a Combination Product	02/26/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		02/26/2018

Labeler - Haloderm, Inc. (080992160)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(71950-0002) , api manufacture(71950-0002) , label(71950-0002) , pack(71950-0002)