FDA.reportPublic FDA data

Charley Horse™ Cream

Manufacturer
Concept Laboratories, Inc. | Filltech USA, LLC
Effective date
2016-02-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:07:31

Label at a glance#

ProductCharley Horse
Active ingredientARNICA MONTANA, CUPRIC ARSENITE, COPPER, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF
Label structure8 sections

Indications and uses

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

Dosage and administration

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

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

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

PRINCIPAL DISPLAY PANEL - 113 G Jar Label
PRINCIPAL DISPLAY PANEL - 113 G Jar Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
c599c4a0-705d-4ebb-ab1f-977af038f96aProduct name120251124
95250459-30e4-45c1-b08a-993044f49109Product name220250805
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64058-159-342020-01-31C16284748780-19d75b9d0-b69b-f424-e053-dadaa90a57ceCharley Horse™ Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64058-159-34Charley Horse113 g in 1 JARCREAM1131

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64058-159CHARLEY HORSE (ARNICA MONTANA, CUPRIC ARSENITE, COPPER, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, AND TOXICODENDRON PUBESCENS LEAF) CREAM [CONCEPT LABORATORIES, INC.]1Legacy NDC, 1 package rows20160220_713b4d05-4905-46cc-a95f-408b0497e079.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64058-15964058-159-34

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
ARNICA MONTANAO80TY208ZWACTIB
CUPRIC ARSENITESK8L60BCSQACTIB
COPPER789U1901C5ACTIB
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATEHF539G9L3QACTIB
TOXICODENDRON PUBESCENS LEAF6IO182RP7AACTIB
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
Caprylyl Glycol00YIU5438UIACT
Cetyl Alcohol936JST6JCNIACT
Dimethicone92RU3N3Y1OIACT
Glyceryl Monostearate230OU9XXE4IACT
GlycerinPDC6A3C0OXIACT
SUNFLOWER OIL3W1JG795YIIACT
Hexylene GlycolKEH0A3F75JIACT
Methyl SalicylateLAV5U5022YIACT
AVOCADO OIL6VNO72PFC1IACT
PhenoxyethanolHIE492ZZ3TIACT
HIGH DENSITY POLYETHYLENEUG00KM4WR7IACT
Potassium Sorbate1VPU26JZZ4IACT
Sodium Acrylate7C98FKB43HIACT
Water059QF0KO0RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f1023b8f-af48-4839-892a-4729295712a6713b4d05-4905-46cc-a95f-408b0497e0792016-02-16WarningsExact identifier
spl id: f1023b8f-af48-4839-892a-4729295712a6
spl set id: 713b4d05-4905-46cc-a95f-408b0497e079

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.