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| Product NDC Code | 76348-455 | ||||
|---|---|---|---|---|---|
| Drug Name | Elevate cbd heating therapy |
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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%
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.Elevate Topical Cream helps unlock the body's ECS receptors to assist in one's well being and is Doctor formulated with menthol and magnesium to aid in relief. Elevate Topical Cream is pharmaceutically produced and lab tested for purity, quality and safety.
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 Massage desired amount into affected skin area no more than 10 times daily or as directed by your doctor. children under 12 years of age: consult your doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Butyrospermum Parkii (Shea) Butter, C13-14 Isoparaffin, Cannabis Sativa (Hempseed) Oil and Hemp Derived Cannabidiol (CBD) Extract, Cetearyl Alcohol, Cetearyl Glucoside, Cocos Nucifera (Coconut) Oil, Deionized Water, Emusifying Wax, Glyceryl Stearate, Grapefruit Oil, Hamamelis Virginiana (Witch Hazel), Laureth-7, Magnesium Chloride, Magnesium Sulfate, Mangifera Indica (Mango) Seed Butter, Mentha Piperita (Peppermint) Oil, Mint Oil, Olea Europaea (Olive) Oil, Olus (Vegetable) Oil, PEG-100, Phenoxyethanol, Polyacrylamide, Stearic Acid
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 external use on muscles and joints where you feel soreness.
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.ELEVATE CBD HEATING THERAPY MENTHOL C13-14 ISOPARAFFIN PEPPERMINT OIL PEPPERMINT WHITE WAX CETOSTEARYL ALCOHOL SHEA BUTTER PHENOXYETHANOL MAGNESIUM SULFATE, UNSPECIFIED COCONUT OIL WATER POLYACRYLAMIDE (10000 MW) MANGIFERA INDICA SEED BUTTER OLIVE OIL CANNABIS SATIVA SEED OIL CANNABIDIOL STEARIC ACID CETEARYL GLUCOSIDE GLYCERYL MONOSTEARATE MENTHOL MENTHOL LAURETH-7 MAGNESIUM CHLORIDE WITCH HAZEL CORN OIL PEG-100 STEARATE TABASCO PEPPER
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.ELEVATE HEATING THERAPY TOPICAL CREAM LABEL 4.0 oz. heating Elevate
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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Call 215.660.9123 or email us at [email protected]
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 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.When using this 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 heating devices.
Storage and handling
Information about safe storage and handling of the drug product.Other information Keep out of direct sunlight.
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 When using this 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 heating devices. Stop use and ask doctor if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Keep out of reach of children. When using this 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 heating devices.
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