HALODERM ADVANCED- dulcamara, nitricum acidum, thuja occidentalis, antimonium crudum, calcarea carbonica, silicea paste
Haloderm, Inc.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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Drug Facts:

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)

ADVANCED

HaloDerm Advanced

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71950-0001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71950-0001-1	5 g in 1 TUBE; Type 0: Not a Combination Product	02/26/2018	01/04/2024

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		02/26/2018	01/04/2024

Labeler - Haloderm, Inc. (080992160)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(71950-0001) , api manufacture(71950-0001) , label(71950-0001) , pack(71950-0001)

Revised: 1/2021

Document Id: 6b4d5d8b-10b6-4238-9634-767c5f50aabb

Set id: c999e328-c522-41b4-adc9-4a2261eebe45

Version: 2

Effective Time: 20210122

Haloderm, Inc.