Active Ingredient
Menthol 5%
Magnificent Menthol Cooling Pain Cream
FDA Label NDC 76348-421
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 Magnificent Menthol Cooling Pain Cream (NDC 76348-421). 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 active ingredient, purpose, warnings, when using this product, stop use and ask a doctor if, keep out of reach of children, directions, inactive ingredients:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical Analgesic
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.
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
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
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 physicial or occupational therapist
- children under 12 years of age: contact physical or occupational therapist
Inactive Ingredients:
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, Deionized Water, Emulsifying Wax,
Hamamelis Virginiana (Witch Hazel) Magnesium Chloride,
Mangifera Indica (Mango) Seed Butter,
Mentha piperita (Peppermint) Leaf Oil, Olea Europaea
(Olive) Oil, Olus Oil (vegetable), Phenoxyethanol, Xanthan Gum
Indications & Usage
Uses
For temporary relief of minor aches and pains of muscles and joints associated with deep muscle therapy treatments.
Dosage & Administration
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.
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