Otc - Active Ingredient
Menthol
Elevate Cooling Therapy Twist Up
FDA Label NDC 76348-456
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 Cooling Therapy Twist Up (NDC 76348-456). 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, otc - keep out of reach of children, otc - purpose, otc - questions, otc - when using, other safety information, statement of identity, 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.
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.
Otc - Purpose
Purpose
Topical Analgesic
Otc - Questions
Questions? Call 215.660.9123 or email us at [email protected]
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.
Other Safety Information
Other information
- Keep out of direct sunlight
Statement Of Identity
elevate CBD COOLING THERAPY TWIST UP TOPICAL with Menthol
Indications & Usage
Uses
- For external use on muscles and joints where you feel soreness
Dosage & Administration
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.
Recent Major Changes
Bullets removed
The word "Directions" was removed
Warnings
Warnings
- For external use only
- When using this product do not bandage tightly
- avoid contact with eyes
- do not apply to to wounds or damaged skin
- do not use with heating pads or other heating devices
Inactive Ingredient
Inactive Ingredients
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, 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
Package Label.Principal Display Panel
elevate Twist Up Topical label
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