HALODERM REGULAR (DULCAMARA, NITRICUM ACIDUM, THUJA OCCIDENTALIS, ANTIMONIUM CRUDUM, CALCAREA CARBONICA, SILICEA) PASTE [HALODERM, INC.]

HALODERM REGULAR (DULCAMARA, NITRICUM ACIDUM, THUJA OCCIDENTALIS, ANTIMONIUM CRUDUM, CALCAREA CARBONICA, SILICEA) PASTE [HALODERM, INC.]
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NDC 71950-0002-1
Set ID a2d372e5-73d5-479c-b781-7aed282dcbca
Category HUMAN OTC DRUG LABEL
Packager Haloderm, Inc.
Generic Name
Product Class
Product Number
Application Number
  • 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

  • INGREDIENTS AND APPEARANCE
    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 Product02/26/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic02/26/2018
    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)

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