BIOCOOL

Manufacturer
JJindustry.Co.Ltd
Effective date
2016-04-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:45:45

Label at a glance#

ProductBIOCOOL Tube Type
Active ingredientMenthol
Label structure8 sections

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: Menthol 4%

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

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 SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children: Keep out of reach of children to avoid accidental ingestion. If swallowed, get medical help immediately.

Usages

INDICATIONS & USAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
415974menthol 4 % Topical GelPSN1
415974menthol 0.04 MG/MG Topical GelSCD1
415974menthol 4 % Topical GelSY1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
QR code linkQR Codewww.biocool.kr/biocool tube type carton.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70612-010-01BIOCOOLTube Type100 mL in 1 TUBEGEL1001
70612-010-02BIOCOOLTube Type1 in 1 CARTONGEL11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70612-010BIOCOOL TUBE TYPE (MENTHOL) GEL [JJINDUSTRY.CO.LTD]1Legacy NDC, 2 package rows20160419_dd430130-eb92-47fc-a113-a1a90d169810.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70612-01070612-010-01, 70612-010-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
MentholL7T10EIP3AACTIB
Water059QF0KO0RIACT
GlycerinPDC6A3C0OXIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
3a3614d6-ca20-4556-b768-6e1598e6aa0bdd430130-eb92-47fc-a113-a1a90d1698102016-04-19WarningsExact identifier
spl id: 3a3614d6-ca20-4556-b768-6e1598e6aa0b
spl set id: dd430130-eb92-47fc-a113-a1a90d169810

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.