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| Product NDC Code | 52000-020 | ||||
|---|---|---|---|---|---|
| Drug Name | Muscle rub |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | GEL | ||||
| RxCUI drug identifier | 282805 | ||||
| Application Number | part348 | ||||
| Labeler Name | Universal Distribution Center LLC | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Menthol 2.5%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions Adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily and gently massage until gel disappears. Children under 12 years of age: do not use, consult a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Camphor, Carbomer, DMDM Hydantoin, Isoceteth, Isopropyl Alcohol, PEG-40 Hydrogenated Castor Oil, Sodium Hydroxide, Water
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses Provides soothing relief of minor arthritis pain, aching muscles, joints and backaches.
Purpose
Information about the drug product’s indications for use.Purpose Topical Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Muscle Rub Menthol CAMPHOR (SYNTHETIC) CARBOMER 940 DMDM HYDANTOIN ISOCETETH-20 ISOPROPYL ALCOHOL POLYOXYL 40 HYDROGENATED CASTOR OIL SODIUM HYDROXIDE WATER MENTHOL MENTHOL
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PRINCIPAL DISPLAY PANEL MUSCLE RUB GEL NET WT 1.25 OZ (35 g) image of package label
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Other Information Store at controlled room temperature 15°C to 30°C (59°F to 86°F) Lot No. & Exp. Date: see crimp of tube.
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.If swallowed, get medical help or contact a Poison Control Center right away.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings For external use only. Use only as directed. Keep out of reach of children to avoid accidental poisoning. Avoid contact with eyes or mucous membranes. Discontinue use if excessive irritation of the skin develops. Do not bandage tightly, apply to wounds, broken or irritated skin, or use with a heating pad. If condition worsens, or if symptoms persist for more than 10 days or clear-up and occur again within a few days, if skin redness or irritation develops, discontinue use of this product and consult a doctor. For arthritis like conditions in children under 12, do not use. Consult a doctor.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API