Otc - Active Ingredient
Menthol 5 percent
Elevate Heating Therapy
FDA Label NDC 76348-458
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 (NDC 76348-458). 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, warnings, otc - keep out of reach of children, otc - purpose, otc - questions, dosage & administration, other safety information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Warnings
For external use only
When using this product do not bandage tightly
avoid contact with eye
do not apply to wounds or damaged skin
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 Poison Control Center right away
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.
Keep out of reach of children
If swallowed get medical help or contact a Poison Control center right away
Otc - Purpose
Topical Analgesic
Otc - 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 ask directed by your doctor.
Children under 12 years of age
consult your physician
Other Safety 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, 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
Statement Of Identity
elevate
CBD
COOLING
THERAPY TOPICAL CREAM
Uses
for external use on muscles and joints where you feel stiffness
Package Label.Principal Display Panel
2 oz. cream Heating Therapy tube
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