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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

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.

Drug Label Information

Updated February 16, 2016

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients HPUSPurpose
    Arnica Montana 4X HPUSAscending leg pain
    Cuprum ars. 10X HPUSCramps in calves
    Cuprum met. 11X HPUSSpasms, leg cramps
    Mag. phos. 10X HPUSCramps in calves
    Rhus Tox. 4X HPUSLeg 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).

  • SPL UNCLASSIFIED SECTION

    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)

    PRINCIPAL DISPLAY PANEL - 113 G Jar Label
  • INGREDIENTS AND APPEARANCE
    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:64058-159
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA4 [hp_X]  in 113 g
    CUPRIC ARSENITE (UNII: SK8L60BCSQ) (CUPRIC CATION - UNII:8CBV67279L, ARSENITE ION - UNII:N5509X556J) CUPRIC ARSENITE10 [hp_X]  in 113 g
    COPPER (UNII: 789U1901C5) (COPPER - UNII:789U1901C5) COPPER11 [hp_X]  in 113 g
    MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE10 [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:64058-159-34113 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC01/29/2016
    Labeler - Concept Laboratories, Inc. (962282612)
    Establishment
    NameAddressID/FEIBusiness Operations
    Concept Laboratories, Inc.962282612LABEL(64058-159)
    Establishment
    NameAddressID/FEIBusiness Operations
    Filltech USA, LLC965596435MANUFACTURE(64058-159)
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