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 HPUSPurpose
Arnica Montana 4X HPUSAscending leg pain
Cuprum ars. 8X HPUSCramps in calves
Cuprum met. 8X HPUSSpasms, leg cramps
Mag. phos. 8X HPUSCramps in calves
Rhus Tox. 4X HPUSLeg 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)

PRINCIPAL DISPLAY PANEL - 113 G Jar Label
CHARLEY HORSE 
arnica montana, cupric arsenite, copper, magnesium phosphate, dibasic trihydrate, and toxicodendron pubescens leaf cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64058-160
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ARNICA MONTANA WHOLE (UNII: O80TY208ZW) (ARNICA MONTANA WHOLE - UNII:O80TY208ZW) ARNICA MONTANA WHOLE4 [hp_X]  in 113 g
CUPRIC ARSENITE (UNII: SK8L60BCSQ) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC ARSENITE8 [hp_X]  in 113 g
COPPER (UNII: 789U1901C5) (COPPER - UNII:789U1901C5) COPPER8 [hp_X]  in 113 g
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE8 [hp_X]  in 113 g
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF4 [hp_X]  in 113 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64058-160-34113 g in 1 JAR; Type 0: Not a Combination Product11/18/201906/26/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved homeopathic11/18/201906/26/2020
Labeler - Concept Laboratories, Inc. (962282612)
Establishment
NameAddressID/FEIBusiness Operations
Concept Laboratories, Inc.962282612LABEL(64058-160)
Establishment
NameAddressID/FEIBusiness Operations
Filltech USA, LLC926433855MANUFACTURE(64058-160)

Revised: 7/2022
Document Id: 9bb21659-2fb2-442f-9d6c-a27dd4f99b71
Set id: 4584c0dd-77ef-4bcc-901a-9008f2c45c10
Version: 2
Effective Time: 20220711
 
Concept Laboratories, Inc.