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Product NDC Code | 70039-283 | ||||
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Drug Name | Professional therapy musclecare pain relieving gel extra strength |
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Type | Brand | ||||
Active Ingredients |
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Route | CUTANEOUS, TOPICAL | ||||
Dosage Form | GEL | ||||
RxCUI drug identifier | 1039731 | ||||
Application Number | part348 | ||||
Labeler Name | Active and Innovative Inc. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients (% by weight) Purpose Camphor 4.0%................................Analgesic (pain relief) Menthol 10.0%.................................Analgesic (pain relief)
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 or older: Using the roll-on applicator massage a liberal amount of gel directly on the affected area not more than 3 to 4 times daily. Children under the age of 12: Do not use, consult a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: Alcohol Denat., Acrylates Copolymer, Water, Eucalyptus Globulus Leaf Oil, Mentha Piperita (Peppermint Oil), Propylene Glycol, Glycerin, MSM (Methylsulfonylmethane), Boswellia Serrata Extract, Ilex Paraguensis (Yerba Mate Ilex) Extract, Glucosamine Sulfate, Chondroitin Sulfate, Magnesium Chloride, Triethanolamine.
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: For temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains, etc.
Purpose
Information about the drug product’s indications for use.FOR MUSCLE & JOINT PAIN RELIEF
Spl product data elements
Usually a list of ingredients in a drug product.Professional Therapy MuscleCare pain relieving gel Extra Strength Camphor, Menthol PROPYLENE GLYCOL ETHYL ACRYLATE/METHACRYLIC ACID/STEARETH-20 METHACRYLATE COPOLYMER WATER EUCALYPTUS OIL CAMPHOR (SYNTHETIC) CAMPHOR (SYNTHETIC) MENTHOL MENTHOL PEPPERMINT OIL GLYCERIN DIMETHYL SULFONE CHONDROITIN SULFATE (CHICKEN) MAGNESIUM CHLORIDE INDIAN FRANKINCENSE ILEX PARAGUARIENSIS LEAF GLUCOSAMINE SULFATE ALCOHOL TROLAMINE
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.Extra Strength Pain Relieving Gel by Dr. Chris Oswald Net Wt 3oz. (85g) Complete Label - MC rollon
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.Keep out of reach of children. - Use only as directed. - Do not use if pregnant or breastfeeding. - If swallowed, get medical help or contact a Poison Control center right away.
Storage and handling
Information about safe storage and handling of the drug product.Other Information: Store under normal storage conditions. Store away from children.
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. - Caution: Discontinue use if excessive irritation of the skin develops. Avoid getting into eyes or on mucous membranes - If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor. - Do not apply to wounds or damaged skin. Do not bandage tightly.
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