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Product NDC Code | 76348-510 | ||||
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Drug Name | Mag 5 pt cooling formula recovery cream |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | CREAM | ||||
Application Number | part348 | ||||
Labeler Name | RENU LABORATORIES, INC. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Menthol 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 no more than three times a day or as directed by your physical or occupational therapist children under 12 years of age: consult your physical or occupational therapist.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Arnica Montana (Arnica) Flower Extract, Butyrospermum Parkii (Shea Butter), Cannabis Sativa (Hemp) Seed Oil and Hemp-Derived Cannabidiol (CBD) Extract, Cetearyl Alcohol, Cetearyl Glucoside, Citrus Paradisi (Grapefruit) Extract, Cocos Nucifera (Coconut) Oil, C13-14 Isoparaffin, Deionized Water, Emulsifying Wax, Hamamelis Virginiana (Witch Hazel), Hippophae Rhamnoides (Sea Berry) Fruit Oil, Hippophae Rhamnoides (Sea Berry) Seed Oil, Laureth-7, Lobelia Flower Extract, Magnesium Chloride, Magnesium Gluconate, Magnesium Myristate, Magnesium Orotate, Magnesium Sulfate, Mangifera Indica (Mango) Seed Butter, Mentha piperita (Peppermint) Leaf Oil, Olea Europaea (Olive) Oil, Olus Oil (vegetable), Phenoxyethanol, Polyacrylamide, Xanthan Gum
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.For temporary relief of minor aches and pains of muscles and joints associated with deep muscle therapy treatments.
Purpose
Information about the drug product’s indications for use.Topical Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Mag 5 PT Cooling Formula Recovery Cream Menthol CANNABIDIOL MAGNESIUM OROTATE MAGNESIUM GLUCONATE HIPPOPHAE RHAMNOIDES SEED OIL WITCH HAZEL NIACINAMIDE MENTHOL MENTHOL CETEARYL GLUCOSIDE PEG-100 STEARATE OLIVE OIL CANNABIS SATIVA SEED OIL PHENOXYETHANOL SHEA BUTTER PEPPERMINT OIL MAGNESIUM SULFATE, UNSPECIFIED CORN OIL POLYACRYLAMIDE (10000 MW) LAURETH-7 MAGNESIUM CHLORIDE C13-14 ISOPARAFFIN CETOSTEARYL ALCOHOL WHITE WAX ARNICA MONTANA FLOWER WATER GLYCERYL MONOSTEARATE LOBELIA INFLATA LEAF STEARIC ACID COCONUT OIL MAGNESIUM MYRISTATE HIPPOPHAE RHAMNOIDES FRUIT OIL MANGIFERA INDICA SEED BUTTER
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.MAG 5 PT 16.0 OZ. LABEL 16 OZ. COOLING LABEL
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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Visit us on the web www.mag5pt.com
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if Condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.Do not bandage tightly avoid contact with eyes do not apply to wounds or damaged skin do not use with heating pads or other heatng devices
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.For external use only
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