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Product NDC Code | 70612-030 | ||||
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Drug Name | Biocool focus on |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | GEL | ||||
RxCUI drug identifier | 808955 | ||||
Application Number | part348 | ||||
Labeler Name | JJindustry.Co.Ltd | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENT Active ingredients: Menthol 3.5%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENT Inactive ingredients: Purified water, isopropyl alcohol, glycerin, phytoncide, peppermint oil, lavender oil, eucalyptus oil, licorice extract, methyl sulfonyl methane, carbomer, sodium hydroxide, PEG-60 hydrogenated castor oil , methyl parahydroxybenzoate, FD & C
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.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.
Purpose
Information about the drug product’s indications for use.PURPOSE Purpose: Topical Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Biocool Focus On Menthol Menthol MENTHOL Water Glycerin
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Image of carton
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.KEEP OUT OF REACH OF CHILDREN Keep out of reach of children
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.WARNINGS Warnings: ▪ Do not use the product if there are any abnormalities such as red spots, swelling or itching. ▪ Do not use the product in the areas with abnormalities such as scratches, eczema and dermatitis. ▪ Do not use the product near the eyes. In case of contact with eyes, wash immediately with water. ▪ Keep out of reach of children. ▪ After use, close the cap tightly and keep it at room temperature.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API