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Drug Facts
Manufactured for: Concept Laboratories, Inc., Chicago, IL 60642 (USA)
www.conceptlabs.org
CL10043
Charley Horse
FDA Label NDC 64058-159
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Concept Laboratories, Inc. for the product Charley Horse (NDC 64058-159). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - purpose, uses, otc - keep out of reach of children, directions, inactive ingredients, principal display panel - 113 g jar label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| Active ingredients HPUS | Purpose |
|---|---|
| Arnica Montana 4X HPUS | Ascending leg pain |
| Cuprum ars. 10X HPUS | Cramps in calves |
| Cuprum met. 11X HPUS | Spasms, leg cramps |
| Mag. phos. 10X 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.
Otc - Keep Out Of Reach Of Children
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).
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)
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