Otc - Active Ingredient
Active Ingredient
Menthol 5%
Elevate Heating Therapy Twist Up
FDA Label NDC 76348-454
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 Heating Therapy Twist Up (NDC 76348-454). 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 - purpose, indications & usage, warnings, otc - stop use, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Topical Analgesic
Indications & Usage
Uses
- For external use on muscles and joints where you feel soreness
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
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.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control center right away.
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 physician.
Other Information
- Keep out of direct sunlight.
Inactive Ingredient
Inactive Ingredients Butyrospermum Parkii (Shea) Butter, C13-14 Isoparaffin, Cannabis Sativa (Hempseed) Oil and Hemp Derived Cannabidiol (CBD) Extract, Capsicum Frutescens (Pepper) Fruit Extract, Cetearyl Alcohol, Cetearyl Glucoside, Cocos Nucifera (Coconut) Oil, Deionized Water, Emulsifying 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
Otc - Questions
Questions? Call 215.660.9123 or email us at [email protected]
Dosage & Administration
Massage desired amount into affected skin area no more than 10 times daily or as directed by your doctor
Recent Major Changes
Dosage and Administration section did not exist prior to 01-06-2020. It was missed and created today.
Bullet mark only was removed.
Removed the word "Directions."
Package Label.Principal Display Panel
Elevate 2oz Cream Stick
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