Otc - Active Ingredient
Menthol 5%
Mag 5 Pt Warming Formula Cream
FDA Label NDC 76348-511
10 label sections · Submitted to the FDA by Renu Laboratories, Llc · 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 Warming Formula (NDC 76348-511). 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 - when using, otc - stop use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Topical Analgesic
Indications & Usage
For temporary relief of minor aches and pains of muscles and joints associated with deep muscle therapy treatments.
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 heating 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 10 times a day or as directed by your physical or occupational therapist
- children under 12 years of age, do not use, consult a doctor.
Inactive Ingredient
Arnica Montana (Arnica) Flower Extract, Butyrospermum Parkii (Shea) Butter, Cannabis Sativa (Hemp) Seed Oil, Cetearyl Alcohol, Cetearyl Glucoside, Cocos Nucifera (Coconut) Oil, Deionized Water, Emulsifying Wax, Fragrance, Hamamelis Virginiana (Witch Hazel), Hemp Derived Cannabidiol (CBD) Extract, Laureth-7, Lobelia Inflata (Lobelia) Extract, Magnesium Chloride, Magnesium Citrate, Magnesium Gluconate, Magnesium Myristate, Magnesium Sulfate, Mangifera Indica (Mango) Seed Buter, Mentha Piperita (Peppermint) Oil, Olea Europaea (Olive) Oil, Olus Oil (Vegetable), Phenoxyethanol, Polyacrylamide C13-14 Isoparaffin, Xanthan Gum
Package Label.Principal Display Panel
MAG5 PT WARMING CREAM LABEL AND PRODUCT BOX
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