Otc - Active Ingredient
Menthol 5%
Elevate Cbd Heating Therapy
FDA Label NDC 76348-455
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Renu Laboratories, Inc. for the product Elevate Cbd Heating Therapy (NDC 76348-455). 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 otc - active ingredient, otc - stop use, warnings, otc - keep out of reach of children, otc - when using, otc - purpose, otc - questions, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Stop Use
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
Warnings
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.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Otc - When Using
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.
Otc - Purpose
Purpose
Topical Analgesic
Otc - Questions
Questions? Call 215.660.9123 or email us at [email protected]
Indications & Usage
Uses: For external use on muscles and joints where you feel soreness.
Dosage & Administration
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
Storage And Handling
Other information
Keep out of direct sunlight.
Inactive Ingredient
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
Description
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.
Package Label.Principal Display Panel
ELEVATE HEATING THERAPY TOPICAL CREAM LABEL
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