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NDC 45341-0002-01 Artalgia 30; 12; 3; 12; 12; 12; 12; 30; 12; 12; 3; 12; 30; 30; 30; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Details

Artalgia 30; 12; 3; 12; 12; 12; 12; 30; 12; 12; 3; 12; 30; 30; 30; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL

Artalgia is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Todd Horton DPM. The primary component is ACTIVATED CHARCOAL; AMANITA MUSCARIA FRUITING BODY; ARNICA MONTANA WHOLE; BARIUM CARBONATE; BELLIS PERENNIS WHOLE; CLAVICEPS PURPUREA SCLEROTIUM; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM WHOLE; LEAD; MERCURIUS SOLUBILIS; MILK THISTLE.

Product Information

NDC	45341-0002
Product ID	45341-0002_2c53f257-54a1-4a2b-aac3-6eaffea91603
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	Artalgia
Proprietary Name Suffix	n/a
Non-Proprietary Name	Carduus Marianus, Arnica Montana, Agaricus Muscarius, Baryta Carbonica, Bellis Perennis, Glonoinum, Hamamelis Virginiana, Mercurius Solubilis, Plumbum Metallicum, Secale Cornutum, Vanadium Metallicum, Carbo Vegetabilis, Hypericum Perforatum, Phosphorus Pu
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	ORAL
Active Ingredient Strength	30; 12; 3; 12; 12; 12; 12; 30; 12; 12; 3; 12; 30; 30; 30; 12
Active Ingredient Units	[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Substance Name	ACTIVATED CHARCOAL; AMANITA MUSCARIA FRUITING BODY; ARNICA MONTANA WHOLE; BARIUM CARBONATE; BELLIS PERENNIS WHOLE; CLAVICEPS PURPUREA SCLEROTIUM; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM WHOLE; LEAD; MERCURIUS SOLUBILIS; MILK THISTLE
Labeler Name	Todd Horton DPM
Pharmaceutical Class	Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]
DEA Schedule	n/a
Marketing Category	UNAPPROVED HOMEOPATHIC
Application Number	n/a
Listing Certified Through	2024-12-31

Package

Package Images

NDC 45341-0002-01 (45341000201)

Pricing Information	N/A
NDC Package Code	45341-0002-1
Billing NDC	45341000201
Package	30 mL in 1 BOTTLE, DROPPER (45341-0002-1)
Marketing Start Date	2020-07-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 9404b908-5b1c-44b0-a9ff-35f3768b8ed7 Details

ACTIVE INGREDIENTS:

Carduus Marianus 3X, Arnica Montana 3X, 12X, Agaricus Muscarius 12X, Baryta Carbonica 12X, Bellis Perennis 12X, Glonoinum 12X, Hamamelis Virginiana 12X, Mercurius Solubilis 12X, Plumbum Metallicum 12X, Secale Cornutum 12X, Vanadium Metallicum 12X, Carbo Vegetabilis 30X, Hypericum Perforatum 30X, Phosphorus 30X, Pulsatilla (Pratensis) 30X, Rhus Tox 30X.

INDICATIONS:

For temporary relief of numbness, tingling, discoloration, coldness, and burning of the lower extremities.

WARNINGS:

Keep out of reach of children. In case of overdose, contact physician or Poison Control Center right away. If pregnant or breast-feeding, seek advice of a health professional before use. Tamper seal: "Sealed for Your Protection." Do not use if seal is broken or missing.

KEEP OUT OF REACH OF CHILDREN:

In case of overdose, contact physician or Poison Control Center right away.

DIRECTIONS:

10 drops orally, 3-4 times daily by mouth. Consult a physician for use in children under 12 years of age.

INDICATIONS AND USAGE:

For temporary relief of numbness, tingling, discoloration, coldness, and burning of the lower extremities.

INACTIVE INGREDIENTS:

Demineralized Water, 25% Ethanol, Ginkgo Extract (leaf) Ginkgo biloba

QUESTIONS:

MFD. FOR:

Todd Horton D.P.M.

3304 Brigadoon Drive

Clearwater, FL 33759

PACKAGE LABEL DISPLAY:

ARTALGIA

BURNING FEET/COLD FEET

Homeopathic

1 FL OZ (30 ml)

INGREDIENTS AND APPEARANCE

ARTALGIA

carduus marianus, arnica montana, agaricus muscarius, baryta carbonica, bellis perennis, glonoinum, hamamelis virginiana, mercurius solubilis, plumbum metallicum, secale cornutum, vanadium metallicum, carbo vegetabilis, hypericum perforatum, phosphorus pulsatilla (pratensis), rhus tox liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:45341-0002
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MILK THISTLE (UNII: U946SH95EE) (MILK THISTLE - UNII:U946SH95EE)	MILK THISTLE	3 [hp_X] in 1 mL
ARNICA MONTANA WHOLE (UNII: O80TY208ZW) (ARNICA MONTANA WHOLE - UNII:O80TY208ZW)	ARNICA MONTANA WHOLE	3 [hp_X] in 1 mL
AMANITA MUSCARIA FRUITING BODY (UNII: DIF093I037) (AMANITA MUSCARIA FRUITING BODY - UNII:DIF093I037)	AMANITA MUSCARIA FRUITING BODY	12 [hp_X] in 1 mL
BARIUM CARBONATE (UNII: 6P669D8HQ8) (BARIUM CATION - UNII:V645272HLN)	BARIUM CARBONATE	12 [hp_X] in 1 mL
BELLIS PERENNIS WHOLE (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY)	BELLIS PERENNIS WHOLE	12 [hp_X] in 1 mL
NITROGLYCERIN (UNII: G59M7S0WS3) (NITROGLYCERIN - UNII:G59M7S0WS3)	NITROGLYCERIN	12 [hp_X] in 1 mL
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS) (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - UNII:T7S323PKJS)	HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK	12 [hp_X] in 1 mL
MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2)	MERCURIUS SOLUBILIS	12 [hp_X] in 1 mL
LEAD (UNII: 2P299V784P) (LEAD - UNII:2P299V784P)	LEAD	12 [hp_X] in 1 mL
CLAVICEPS PURPUREA SCLEROTIUM (UNII: 01G9XEA93N) (CLAVICEPS PURPUREA SCLEROTIUM - UNII:01G9XEA93N)	CLAVICEPS PURPUREA SCLEROTIUM	12 [hp_X] in 1 mL
VANADIUM (UNII: 00J9J9XKDE) (VANADIUM - UNII:00J9J9XKDE)	VANADIUM	12 [hp_X] in 1 mL
ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (ACTIVATED CHARCOAL - UNII:2P3VWU3H10)	ACTIVATED CHARCOAL	30 [hp_X] in 1 mL
HYPERICUM PERFORATUM WHOLE (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB)	HYPERICUM PERFORATUM WHOLE	30 [hp_X] in 1 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	30 [hp_X] in 1 mL
PULSATILLA PRATENSIS WHOLE (UNII: 8E272251DI) (PULSATILLA PRATENSIS WHOLE - UNII:8E272251DI)	PULSATILLA PRATENSIS WHOLE	30 [hp_X] in 1 mL
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A)	TOXICODENDRON PUBESCENS LEAF	30 [hp_X] in 1 mL

Ingredient Name	Strength
Inactive Ingredients
GINKGO (UNII: 19FUJ2C58T)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:45341-0002-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	07/15/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		07/15/2020

Labeler - Todd Horton DPM (056556083)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(45341-0002) , api manufacture(45341-0002) , label(45341-0002) , pack(45341-0002)

Revised: 7/2020

Document Id: 2c53f257-54a1-4a2b-aac3-6eaffea91603

Set id: 9404b908-5b1c-44b0-a9ff-35f3768b8ed7

Version: 1

Effective Time: 20200715