Otc - Active Ingredient
Menthol 5%
Mag 5 Pt Cooling Formula Recovery Cream
FDA Label NDC 76348-510
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, Llc for the product Mag 5 Pt Cooling Formula Recovery Cream (NDC 76348-510). 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, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Topical Analgesic
Warnings
For external use only
Otc - When Using
Do not bandage tightly
avoid contact with eyes
do not apply to wounds or damaged skin
do not use with heating pads or other heatng devices
Otc - Stop Use
Stop use and ask a 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
If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions Adults and children 12 years of age and older, apply to affected area no more than three times a day or as directed by your physical or occupational therapist
- children under 12 years of age: consult your physical or occupational therapist.
Inactive Ingredient
Arnica Montana (Arnica) Flower Extract, Butyrospermum Parkii (Shea Butter), Cannabis Sativa (Hemp) Seed Oil and Hemp-Derived Cannabidiol (CBD) Extract, Cetearyl Alcohol, Cetearyl Glucoside, Citrus Paradisi (Grapefruit) Extract, Cocos Nucifera (Coconut) Oil, C13-14 Isoparaffin, Deionized Water, Emulsifying Wax, Hamamelis Virginiana (Witch Hazel), Hippophae Rhamnoides (Sea Berry) Fruit Oil, Hippophae Rhamnoides (Sea Berry) Seed Oil, Laureth-7, Lobelia Flower Extract, Magnesium Chloride, Magnesium Gluconate, Magnesium Myristate, Magnesium Orotate, Magnesium Sulfate, Mangifera Indica (Mango) Seed Butter, Mentha piperita (Peppermint) Leaf Oil, Olea Europaea (Olive) Oil, Olus Oil (vegetable), Phenoxyethanol, Polyacrylamide, Xanthan Gum
Otc - Questions
Visit us on the web www.mag5pt.com
Indications & Usage
for temporary relief of minor aches and pains of muscles and joints associated with deep muscle therapy treatments.
* Please review the disclaimer below.
