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NDC 71950-0002-01 HaloDerm Regular 12; 10; 12; 12; 10; 10 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Details

HaloDerm Regular 12; 10; 12; 12; 10; 10 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g

HaloDerm Regular is a TOPICAL PASTE in the HUMAN OTC DRUG category. It is labeled and distributed by Haloderm, Inc.. The primary component is ANTIMONY TRISULFIDE; NITRIC ACID; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SILICON DIOXIDE; SOLANUM DULCAMARA TOP; THUJA OCCIDENTALIS LEAFY TWIG.

Product Information

NDC	71950-0002
Product ID	71950-0002_c52aadf3-c483-4a57-8ce0-263dfceeac91
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	HaloDerm Regular
Proprietary Name Suffix	n/a
Non-Proprietary Name	Dulcamara, Nitricum Acidum, Thuja Occidentalis, Antimonium Crudum, Calcarea Carbonica, Silicea
Product Type	HUMAN OTC DRUG
Dosage Form	PASTE
Route	TOPICAL
Active Ingredient Strength	12; 10; 12; 12; 10; 10
Active Ingredient Units	[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g
Substance Name	ANTIMONY TRISULFIDE; NITRIC ACID; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SILICON DIOXIDE; SOLANUM DULCAMARA TOP; THUJA OCCIDENTALIS LEAFY TWIG
Labeler Name	Haloderm, Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	UNAPPROVED HOMEOPATHIC
Application Number	n/a
Listing Certified Through	n/a

Package

Package Images

NDC 71950-0002-01 (71950000201)

Pricing Information	N/A
NDC Package Code	71950-0002-1
Billing NDC	71950000201
Package	5 g in 1 TUBE (71950-0002-1)
Marketing Start Date	2018-02-26
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a2d372e5-73d5-479c-b781-7aed282dcbca Details

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

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:71950-0002-1	5 g in 1 TUBE; Type 0: Not a Combination Product	02/26/2018	07/16/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		02/26/2018	07/16/2023

Labeler - Haloderm, Inc. (080992160)

Registrant - Apotheca Company (844330915)

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

Revised: 5/2022

Document Id: c52aadf3-c483-4a57-8ce0-263dfceeac91

Set id: a2d372e5-73d5-479c-b781-7aed282dcbca

Version: 2

Effective Time: 20220506

Search by Drug Name or NDC

NDC 71950-0002-01 HaloDerm Regular 12; 10; 12; 12; 10; 10 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Details

HaloDerm Regular 12; 10; 12; 12; 10; 10 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g

Product Information

Package

Package Images

NDC 71950-0002-01 (71950000201)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL a2d372e5-73d5-479c-b781-7aed282dcbca Details

ACTIVE INGREDIENTS:

INDICATIONS:

WARNINGS:

KEEP OUT OF REACH OF CHILDREN:

DIRECTIONS:

INDICATIONS:

INACTIVE INGREDIENTS:

QUESTIONS:

PACKAGE LABEL DISPLAY:

INGREDIENTS AND APPEARANCE

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