CHARLEY HORSE- arnica montana, cupric arsenite, copper, magnesium phosphate, dibasic trihydrate, and toxicodendron pubescens leaf cream

Charley Horse by

Drug Labeling and Warnings

Charley Horse by is a Homeopathic medication manufactured, distributed, or labeled by Concept Laboratories, Inc., Filltech USA, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients HPUS	Purpose
Arnica Montana 4X HPUS	Ascending leg pain
Cuprum ars. 8X HPUS	Cramps in calves
Cuprum met. 8X HPUS	Spasms, leg cramps
Mag. phos. 8X HPUS	Cramps in calves
Rhus Tox. 4X HPUS	Leg pain, cramps in calves

Warnings

If symptoms persist or worsen, discontinue use and consult a physician. If you are pregnant or nursing seek the advice of a doctor before using.

Keep out of reach of children.

Directions

Apply liberally to affected area. Massage gently until completely absorbed. Repeat as needed.

Inactive ingredients

Caprylic/Capric Triglyceride, Caprylyl Glycol, Cetyl Alcohol, Dimethicone, Glyceryl Monostearate, Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Hexylene Glycol, Methyl Salicylate, Persea Gratissima (Avocado) Oil, Phenoxyethanol, Polyethylene, Potassium Sorbate, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Sodium Polyacrylate, Water (Aqua).

PRINCIPAL DISPLAY PANEL - 113 G Jar Label

HOMEOPATHIC

Charley Horse™ Cream

LEG CRAMP RELIEF

NET WT 4 OZ (113 G)

INGREDIENTS AND APPEARANCE

CHARLEY HORSE 
arnica montana, cupric arsenite, copper, magnesium phosphate, dibasic trihydrate, and toxicodendron pubescens leaf cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64058-160
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	4 [hp_X]  in 113 g
CUPRIC ARSENITE (UNII: SK8L60BCSQ) (CUPRIC CATION - UNII:8CBV67279L)	CUPRIC ARSENITE	8 [hp_X]  in 113 g
COPPER (UNII: 789U1901C5) (COPPER - UNII:789U1901C5)	COPPER	8 [hp_X]  in 113 g
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE	8 [hp_X]  in 113 g
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A)	TOXICODENDRON PUBESCENS LEAF	4 [hp_X]  in 113 g

Inactive Ingredients
Ingredient Name	Strength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
Caprylyl Glycol (UNII: 00YIU5438U)
Cetyl Alcohol (UNII: 936JST6JCN)
Dimethicone (UNII: 92RU3N3Y1O)
Glyceryl Monostearate (UNII: 230OU9XXE4)
Glycerin (UNII: PDC6A3C0OX)
SUNFLOWER OIL (UNII: 3W1JG795YI)
Hexylene Glycol (UNII: KEH0A3F75J)
Methyl Salicylate (UNII: LAV5U5022Y)
AVOCADO OIL (UNII: 6VNO72PFC1)
Phenoxyethanol (UNII: HIE492ZZ3T)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
Potassium Sorbate (UNII: 1VPU26JZZ4)
Sodium Acrylate (UNII: 7C98FKB43H)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64058-160-34	113 g in 1 JAR; Type 0: Not a Combination Product	11/18/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved homeopathic		11/18/2019

Labeler - Concept Laboratories, Inc. (962282612)

Establishment
Name	Address	ID/FEI	Business Operations
Concept Laboratories, Inc.		962282612	LABEL(64058-160)

Establishment
Name	Address	ID/FEI	Business Operations
Filltech USA, LLC		926433855	MANUFACTURE(64058-160)