FDA.reportPublic FDA data

Charley Horse™ Cream

Manufacturer
Concept Laboratories, Inc. | Filltech USA, LLC
Effective date
2019-11-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:57:57

Label at a glance#

ProductCharley Horse
Active ingredientARNICA MONTANA, CUPRIC ARSENITE, COPPER, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF
Label structure6 sections

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

INDICATIONS & USAGE SECTION
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

WARNINGS 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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, 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

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64058-160-342022-07-11C16284748780-1d6a99b39-9f28-a426-e053-dadaa90af4c2Charley Horse™ Cream
64058-160-342022-01-28C16284748780-1d6a99b39-9f28-a426-e053-dadaa90af4c2Charley Horse™ Cream

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64058-16064058-160-34

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
9bb21659-2fb2-442f-9d6c-a27dd4f99b714584c0dd-77ef-4bcc-901a-9008f2c45c102022-07-11WarningsExact identifier
spl set id: 4584c0dd-77ef-4bcc-901a-9008f2c45c10

Reported adverse events (FAERS/openFDA)#

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