Otc - Active Ingredient
Active Ingredients
Menthol 5 percent
Ak47 Menthol Warming
FDA Label NDC 76348-575
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 Ak47 Menthol Warming (NDC 76348-575). 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, otc - when using, warnings, 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
Purpose
Topical Analgesic
Indications & Usage
Uses: for temporary relief of minor aches and pains associated with
- arthritis
- simple backache
- muscle strains
- sprains
- bruises
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 heating pads or other heating devices.
Warnings
Warnings
For external use only
Avoid contact with eyes and sensitive areas
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
Keep out of reach of children
If swallowed, seek medical help or contact a poison control center right away
Dosage & Administration
Directions
adults and children 12 years of age and older
- apply liberally to affected area
- massage into painful area until thoroughly absorbed into skin
- repeat as necessary
Inactive Ingredient
Butyrospermum Parkii (Shea) Butter, Cannabis Sativa Hemp Seed Oil and Hemp Derived Cannabidiol (CBD) Extract with proprietary terpene blend (Limonene, Myrcene, Caryophyllene, Linalool, Pinene, Terpineol), Capsicum Frutescens Fruit Extract, Cetearyl Alcohol, Cetearyl Glucoside, Cocos Nucifera (Coconut) Oil, C13-14 Isoparaffin, Deionized Water, Emulsifying Wax, Fragrance, Glyceryl Stearate, Hamamelis Virginiana (Witch Hazel), Laureth-7, Magnesium Chloride, Mangifera Indica (Mango) Seed Butter, Mentha piperita (Peppermint) Leaf Oil, Olea Europaea (Olive) Fruit Oil, Olus Oil (Vegetable), PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Stearic Acid
Otc - Questions
Questions
* Please review the disclaimer below.
