Otc - Active Ingredient
Menthol
5%
Ak47 Menthol Warming
FDA Label NDC 76348-521
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 76348-521). 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 - stop use, otc - keep out of reach of children, otc - purpose, otc - questions, otc - when using, warnings, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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, get medical help or contact a poison control center right away
Otc - Purpose
Topical Analgesic
Otc - Questions
Questions or Comments
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
For external use only
Indications & Usage
Uses: for temporary relief of minor aches and pains associated with
- arthritis
- simple backache
- muscle strains
- sprains
- bruises
Directions
adults and children 12 years of age and older
- apply generously to affected area
- massage into painful area until thoroughy 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), 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.
Package Label.Principal Display Panel
COOLING CREAM LABEL
COOLING CREAM BOX
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