Indications and uses
temporarily relieves muscle pains, spasms and cramps in calves, feet and legs. Night cramps & pain in lower limbs.
Charley Horse™ Cream
- Manufacturer
- Concept Laboratories, Inc. | Filltech USA, LLC
- Effective date
- 2014-05-16
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 02:05:44
Label at a glance#
ProductCharley Horse
Active ingredientARNICA MONTANA, CUPRIC ARSENITE, COPPER, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF
Label structure7 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
| Active ingredients HPUS | Purpose |
|---|---|
| Arnica Montana 4X HPUS | Ascending leg pain |
| Cuprum ars. 8X HPUS | Cramps in calves |
| Cuprum met. 8X HPUS | Spasms, leg cramps |
| Mag. phos. 8X 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
OTC - ASK DOCTOR SECTION
If symptoms persist or worsen, discontinue use and consult a physician.
OTC - PREGNANCY OR BREAST FEEDING SECTION
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
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).
PRINCIPAL DISPLAY PANEL - 113 G Jar Label
HOMEOPATHIC
Charley Horse™ Cream
LEG CRAMP RELIEF
NET WT 4 OZ (113 G)
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 64058-154-34 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-fff4-f424-e053-dadaa90a57ce | Charley Horse™ Cream |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 64058-154-34 | Charley Horse | 113 g in 1 JAR | CREAM | 113 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 64058-154 | CHARLEY HORSE (ARNICA MONTANA, CUPRIC ARSENITE, COPPER, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, AND TOXICODENDRON PUBESCENS LEAF) CREAM [CONCEPT LABORATORIES, INC.] | 1 | Legacy NDC, 1 package rows | 20140517_6d7b1404-4d0f-4631-8065-e49b69d3b342.zip |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ARNICA MONTANA | ACTIVE INGREDIENT | O80TY208ZW | 1 | |
| COPPER | ACTIVE INGREDIENT | 789U1901C5 | 1 | |
| CUPRIC ARSENITE | ACTIVE INGREDIENT | SK8L60BCSQ | 1 | |
| MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE | ACTIVE INGREDIENT | HF539G9L3Q | 1 | |
| TOXICODENDRON PUBESCENS LEAF | ACTIVE INGREDIENT | 6IO182RP7A | 1 | |
| ARNICA MONTANA | ACTIVE MOIETY | O80TY208ZW | 1 | |
| ARSENITE ION | ACTIVE MOIETY | N5509X556J | 1 | |
| COPPER | ACTIVE MOIETY | 789U1901C5 | 1 | |
| MAGNESIUM CATION | ACTIVE MOIETY | T6V3LHY838 | 1 | |
| TOXICODENDRON PUBESCENS LEAF | ACTIVE MOIETY | 6IO182RP7A | 1 | |
| AVOCADO OIL | INACTIVE INGREDIENT | 6VNO72PFC1 | 1 | |
| Caprylyl Glycol | INACTIVE INGREDIENT | 00YIU5438U | 1 | |
| Cetyl Alcohol | INACTIVE INGREDIENT | 936JST6JCN | 1 | |
| Dimethicone | INACTIVE INGREDIENT | 92RU3N3Y1O | 1 | |
| Glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| Glyceryl Monostearate | INACTIVE INGREDIENT | 230OU9XXE4 | 1 | |
| Hexylene Glycol | INACTIVE INGREDIENT | KEH0A3F75J | 1 | |
| HIGH DENSITY POLYETHYLENE | INACTIVE INGREDIENT | UG00KM4WR7 | 1 | |
| MEDIUM-CHAIN TRIGLYCERIDES | INACTIVE INGREDIENT | C9H2L21V7U | 1 | |
| Methyl Salicylate | INACTIVE INGREDIENT | LAV5U5022Y | 1 | |
| Phenoxyethanol | INACTIVE INGREDIENT | HIE492ZZ3T | 1 | |
| Potassium Sorbate | INACTIVE INGREDIENT | 1VPU26JZZ4 | 1 | |
| Sodium Acrylate | INACTIVE INGREDIENT | 7C98FKB43H | 1 | |
| SUNFLOWER OIL | INACTIVE INGREDIENT | 3W1JG795YI | 1 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Products#
Every source-derived product name is available through these pages.
- Charley Horse
- ARNICA MONTANA, CUPRIC ARSENITE, COPPER, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, and TOXICODENDRON PUBESCENS LEAF
- ARNICA MONTANA
- CUPRIC ARSENITE
- CUPRIC CATION
- ARSENITE ION
- COPPER
- MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE
- MAGNESIUM CATION
- TOXICODENDRON PUBESCENS LEAF
- MEDIUM-CHAIN TRIGLYCERIDES
- Caprylyl Glycol
- Cetyl Alcohol
- Dimethicone
- Glyceryl Monostearate
- Glycerin
- SUNFLOWER OIL
- Hexylene Glycol
- Methyl Salicylate
- AVOCADO OIL
- Phenoxyethanol
- HIGH DENSITY POLYETHYLENE
- Potassium Sorbate
- Sodium Acrylate
- Water
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 64058-154 | 64058-154-34 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| Potassium Sorbate | POTASSIUM SORBATE | 1VPU26JZZ4 | EMULSION / OPHTHALMIC | 0.47 %w/v | ||
| HIGH DENSITY POLYETHYLENE | HIGH DENSITY POLYETHYLENE | UG00KM4WR7 | SYSTEM / TRANSDERMAL | NA | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | PASTE / DENTAL | 20 %w/w | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | JELLY / TOPICAL | NA | ||
| Cetyl Alcohol | CETYL ALCOHOL | 936JST6JCN | EMULSION / TOPICAL | NA | ||
| Glyceryl Monostearate | GLYCERYL MONOSTEARATE | 230OU9XXE4 | OINTMENT / TOPICAL | 5 %w/w | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | GEL / TRANSDERMAL | 500 mg | ||
| HIGH DENSITY POLYETHYLENE | HIGH DENSITY POLYETHYLENE | UG00KM4WR7 | TABLET, DELAYED RELEASE / ORAL | NA | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SUSPENSION / AURICULAR (OTIC) | 0.05 %w/w | ||
| Phenoxyethanol | PHENOXYETHANOL | HIE492ZZ3T | AEROSOL / TOPICAL | 1.05 %w/w | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SUSPENSION / OPHTHALMIC | 58 mg | ||
| Cetyl Alcohol | CETYL ALCOHOL | 936JST6JCN | OINTMENT / TOPICAL | 7 %w/w | ||
| Hexylene Glycol | HEXYLENE GLYCOL | KEH0A3F75J | CREAM / TOPICAL | 385 mg | ||
| HIGH DENSITY POLYETHYLENE | HIGH DENSITY POLYETHYLENE | UG00KM4WR7 | TAPE / TOPICAL | NA | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SUSPENSION/ DROPS / OPHTHALMIC | 2.5 %w/v | ||
| HIGH DENSITY POLYETHYLENE | HIGH DENSITY POLYETHYLENE | UG00KM4WR7 | JELLY / VAGINAL | 42.6 %w/w | ||
| Potassium Sorbate | POTASSIUM SORBATE | 1VPU26JZZ4 | GRANULE, FOR SUSPENSION / ORAL | 80 mg | ||
| Potassium Sorbate | POTASSIUM SORBATE | 1VPU26JZZ4 | LOTION / TOPICAL | 0.2 %w/w | ||
| Potassium Sorbate | POTASSIUM SORBATE | 1VPU26JZZ4 | SYRUP / ORAL | 2 mg/1ml | ||
| Hexylene Glycol | HEXYLENE GLYCOL | KEH0A3F75J | SOLUTION / TOPICAL | 0.3 %w/w | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | GEL / TOPICAL | 12 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | TABLET / ORAL | 42 mg | ||
| Glyceryl Monostearate | GLYCERYL MONOSTEARATE | 230OU9XXE4 | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 23 mg | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | INJECTION, SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS | 990.3 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION/ DROPS / OPHTHALMIC | 12 mg | ||
| Phenoxyethanol | PHENOXYETHANOL | HIE492ZZ3T | CREAM / TOPICAL | 57 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION/ DROPS / AURICULAR (OTIC) | 25 mg | ||
| HIGH DENSITY POLYETHYLENE | HIGH DENSITY POLYETHYLENE | UG00KM4WR7 | CAPSULE, EXTENDED RELEASE / ORAL | 4.53 mg | ||
| Phenoxyethanol | PHENOXYETHANOL | HIE492ZZ3T | AEROSOL, FOAM / TOPICAL | 72 mg | ||
| HIGH DENSITY POLYETHYLENE | HIGH DENSITY POLYETHYLENE | UG00KM4WR7 | PASTE / TOPICAL | 2.5 %w/w | ||
| Potassium Sorbate | POTASSIUM SORBATE | 1VPU26JZZ4 | SOLUTION/ DROPS / OPHTHALMIC | 0.47 %w/v | ||
| Phenoxyethanol | PHENOXYETHANOL | HIE492ZZ3T | LOTION / TOPICAL | 1 %w/w | ||
| Methyl Salicylate | METHYL SALICYLATE | LAV5U5022Y | TABLET / ORAL | 10 mg | ||
| Cetyl Alcohol | CETYL ALCOHOL | 936JST6JCN | SOLUTION / TOPICAL | NA | ||
| Cetyl Alcohol | CETYL ALCOHOL | 936JST6JCN | CREAM / VAGINAL | 200 mg | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | POWDER / SUBLINGUAL | 2 mg | ||
| Methyl Salicylate | METHYL SALICYLATE | LAV5U5022Y | DOUCHE / VAGINAL | 0.05 %w/w | ||
| Cetyl Alcohol | CETYL ALCOHOL | 936JST6JCN | AEROSOL, FOAM / RECTAL | 17 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SUSPENSION, EXTENDED RELEASE / ORAL | 2000 mg | ||
| Potassium Sorbate | POTASSIUM SORBATE | 1VPU26JZZ4 | TABLET, EXTENDED RELEASE / ORAL | 0.2 mg | ||
| HIGH DENSITY POLYETHYLENE | HIGH DENSITY POLYETHYLENE | UG00KM4WR7 | SUPPOSITORY / VAGINAL | NA | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | INJECTION, SOLUTION / SUBCUTANEOUS | 15 %w/v | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | POWDER, FOR SUSPENSION / ORAL | 3390 mg/5ml | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | INJECTION, SOLUTION / INTRAVENOUS | 15 %w/v | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | CREAM, AUGMENTED / TOPICAL | 55 mg | ||
| Glyceryl Monostearate | GLYCERYL MONOSTEARATE | 230OU9XXE4 | SUPPOSITORY / RECTAL | 35 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SUSPENSION / ORAL | 26208 mg | ||
| Potassium Sorbate | POTASSIUM SORBATE | 1VPU26JZZ4 | SPRAY, METERED / NASAL | 0.06 mg | ||
| Cetyl Alcohol | CETYL ALCOHOL | 936JST6JCN | AEROSOL, FOAM / TOPICAL | 82 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | CAPSULE, EXTENDED RELEASE / ORAL | 265 mg | ||
| Cetyl Alcohol | CETYL ALCOHOL | 936JST6JCN | TABLET, FILM COATED / ORAL | NA | ||
| Phenoxyethanol | PHENOXYETHANOL | HIE492ZZ3T | GEL / TOPICAL | 14 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | INJECTION / INTRAMUSCULAR | 450 mg | ||
| HIGH DENSITY POLYETHYLENE | HIGH DENSITY POLYETHYLENE | UG00KM4WR7 | SUPPOSITORY / RECTAL | NA | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | LIQUID / TOPICAL | 2.5 %w/w | ||
| Potassium Sorbate | POTASSIUM SORBATE | 1VPU26JZZ4 | CONCENTRATE / ORAL | 1 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | GEL / OPHTHALMIC | 0.88 %w/w | ||
| Glyceryl Monostearate | GLYCERYL MONOSTEARATE | 230OU9XXE4 | SUSPENSION / OPHTHALMIC | 0.5 %w/v | ||
| HIGH DENSITY POLYETHYLENE | HIGH DENSITY POLYETHYLENE | UG00KM4WR7 | TABLET, EXTENDED RELEASE / ORAL | 0.64 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | LOTION / TOPICAL | 3990 mg |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 107a3124-8cd1-4428-8e1d-e44f773d2d2b | 6d7b1404-4d0f-4631-8065-e49b69d3b342 | 2014-05-16 | Warnings | 107a3124-8cd1-4428-8e1d-e44f773d2d2b 6d7b1404-4d0f-4631-8065-e49b69d3b342 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.