CHARLEY HORSE- arnica montana, cupric arsenite, copper, magnesium phosphate, dibasic trihydrate, and toxicodendron pubescens leaf cream
Concept Laboratories, 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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Charley Horse™ Cream

Drug Facts

Active ingredients HPUS	Purpose
Arnica Montana 4X HPUS	Ascending leg pain
Cuprum ars. 10X HPUS	Cramps in calves
Cuprum met. 11X HPUS	Spasms, leg cramps
Mag. phos. 10X HPUS	Cramps in calves
Rhus Tox. 4X HPUS	Leg pain, cramps in calves

Uses

temporarily relieves muscle pains, spasms and cramps in calves, feet and legs. Night cramps & pain in lower limbs.

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, Gycerin, Helianthus Annuus (Sunflower) Seed Oil, Hexylene Glycol, Methyl Salicylate, Persea Gratissima (Avocado) Oil, Phenoxyethanol, Polyethylene, Potassium Sorbate, Sodium Acrylate/Sodium Acryloyl Dimethyl Taurate Copolymer, Sodium Polyacrylate, Water (Aqua).

Manufactured for: Concept Laboratories, Inc., Chicago, IL 60642 (USA)
www.conceptlabs.org
CL10043

PRINCIPAL DISPLAY PANEL - 113 G Jar Label

HOMEOPATHIC
Charley Horse™ Cream
Leg Cramp Relief
NET WT 4 OZ (113 G)

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:64058-159
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	4 [hp_X] in 113 g
CUPRIC ARSENITE (UNII: SK8L60BCSQ) (CUPRIC CATION - UNII:8CBV67279L, ARSENITE ION - UNII:N5509X556J)	CUPRIC ARSENITE	10 [hp_X] in 113 g
COPPER (UNII: 789U1901C5) (COPPER - UNII:789U1901C5)	COPPER	11 [hp_X] in 113 g
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE	10 [hp_X] in 113 g
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A)	TOXICODENDRON PUBESCENS LEAF	4 [hp_X] in 113 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:64058-159-34	113 g in 1 JAR; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
UNAPPROVED HOMEOPATHIC		01/29/2016

Labeler - Concept Laboratories, Inc. (962282612)

Name	Address	ID/FEI	Business Operations
Establishment
Concept Laboratories, Inc.		962282612	LABEL(64058-159)

Name	Address	ID/FEI	Business Operations
Establishment
Filltech USA, LLC		965596435	MANUFACTURE(64058-159)