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Product NDC Code | 70612-010 | ||||
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Drug Name | Biocool tube type |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | GEL | ||||
RxCUI drug identifier | 415974 | ||||
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 Ingredient: Menthol 4%
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, Camphor, Glycerin, Glycyrrhiza Glabra Root Extract, Methyl sulfonyl methane, Carbomer, PEG-60 Hydrogenated Caster Oil, Methylparaben, Sodium Hydroxide, FD&C blue #1(CI42090), Flavoring.
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: 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.
Spl product data elements
Usually a list of ingredients in a drug product.BIOCOOL Tube Type 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: Keep out of reach of children to avoid accidental ingestion. If swallowed, get medical help immediately.
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: 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.
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