HALODERM REGULAR- 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)
REGULAR

HaloDerm Regular

HALODERM REGULAR 
dulcamara, nitricum acidum, thuja occidentalis, antimonium crudum, calcarea carbonica, silicea paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71950-0002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SOLANUM DULCAMARA TOP (UNII: KPS1B1162N) (SOLANUM DULCAMARA TOP - UNII:KPS1B1162N) SOLANUM DULCAMARA TOP10 [hp_X]  in 1 g
NITRIC ACID (UNII: 411VRN1TV4) (NITRIC ACID - UNII:411VRN1TV4) NITRIC ACID10 [hp_X]  in 1 g
THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397) THUJA OCCIDENTALIS LEAFY TWIG10 [hp_X]  in 1 g
ANTIMONY TRISULFIDE (UNII: F79059A38U) (ANTIMONY TRISULFIDE - UNII:F79059A38U) ANTIMONY TRISULFIDE12 [hp_X]  in 1 g
OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE12 [hp_X]  in 1 g
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE12 [hp_X]  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71950-0002-15 g in 1 TUBE; Type 0: Not a Combination Product02/26/201807/16/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic02/26/201807/16/2023
Labeler - Haloderm, Inc. (080992160)
Registrant - Apotheca Company (844330915)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Company844330915manufacture(71950-0002) , api manufacture(71950-0002) , label(71950-0002) , pack(71950-0002)

Revised: 5/2022
 
Haloderm, Inc.