Ak47 Cooling Roll-on
FDA Label NDC 76348-570

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 Cooling Roll-on (NDC 76348-570). 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 - Active Ingredient

→ Otc - Purpose

→ Indications & Usage

→ Warnings

→ Otc - When Using

→ Otc - Stop Use

→ Otc - Keep Out Of Reach Of Children

→ Dosage & Administration

→ Inactive Ingredient

→ Otc - Questions

→ Statement Of Identity

→ Recent Major Changes

→ Label And Box

Otc - Active Ingredient

Active ingredient: Menthol 1.25%

Otc - Purpose

Purpose Topical Analgesic

Indications & Usage

Uses

for temporary relief of minor aches and pains of muscles and joints associated with

bruises
sprains
arthritis
strains

Warnings

For external use only.

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 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

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 as needed for pain.
children under 12 years of age: do not use, consult a doctor.

Inactive Ingredient

Inactive Ingredients:

Arnica Montana (Arnica) Flower Extract, Cannabis Sativa (Hemp) Seed Oil and Hemp Derived Cannabidiol (CBD) Extract with proprietary terpene blend (Limonene, Myrcene, Caryophyllene, Linalool, Pinene, Terpineol), Deionized Water, Fragrance, Hydroxyethyl Cellulose, Isopropyl Alcohol, Magnesium Chloride, Mentha piperita (Peppermint) Leaf Oil, Polysorbate 80, Potassium Sorbate, Sodium Benzoate, Virginiana Hamamelis (Witch Hazel).