Active Ingredient
Active Ingredient: Menthol 4%
Biocool
FDA Label NDC 70612-010
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Jjindustry.co.ltd for the product Biocool (NDC 70612-010). 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, inactive ingredient, purpose, warnings, keep out of reach of children, usages, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
Inactive Ingredients: Purified Water, Isopropyl Alcohol, Camphor, Glycerin, Glycyrrhiza Glabra Root Extract, Methyl sulfonyl methane, Carbomer, PEG-60 Hydrogenated Caster Oil, Methylparaben, Sodium Hydroxide, FD&C blue #1(CI42090), Flavoring.
Purpose
Purpose: BIOCOOL Sports Gel is specially formulated for the temporary activation from muscle and joint stiffness through cooling and refreshing effect. It is patented for the formulation, which contains Menthol, Camphor, and Glycyrrhiza Glabra Root Extract, Methyl sulfonyl methane. Patient response to ultrasound and sports massage therapy is enhanced when BIOCOOL Sports Gel is used to help prior to the ultrasound and massage treatments.
Warnings
Warnings: Use only as directed. For external use only. Avoid contact with the eyes. Do not apply to wounds or damaged skin. Do not apply to irritated skin or if excessive irritation develops. Store at room temperature with lid closed tightly. Keep away from excessive heat or open flame. Do not use with heating pads or devices.
Keep Out Of Reach Of Children
Keep out of reach of children: Keep out of reach of children to avoid accidental ingestion. If swallowed, get medical help immediately.
Usages
Usages: For the activation of muscle and joint. For use with ultrasonic transmission treatments and sports massage. Apply appropriate amount onto affected area and rub until fully absorbed. It's more effective when applied 2~3 times repeatedly.
Usages: For the activation of muscle and joint. For use with ultrasonic transmission treatments and sports massage. Apply appropriate amount onto affected area and rub until fully absorbed. It's more effective when applied 2~3 times repeatedly.
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