Label: BIOCOOL TUBE TYPE- menthol gel
- NDC Code(s): 70612-010-01, 70612-010-02
- Packager: JJindustry.Co.Ltd
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated April 19, 2016
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- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
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: 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
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
BIOCOOL TUBE TYPE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70612-010 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Menthol (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) Menthol 4.0 g in 100 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Glycerin (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70612-010-02 1 in 1 CARTON 03/02/2016 1 NDC:70612-010-01 100 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 03/02/2016 Labeler - JJindustry.Co.Ltd (689605084) Registrant - JJindustry.Co.Ltd (689605084) Establishment Name Address ID/FEI Business Operations JJindustry.Co.Ltd 689605084 manufacture(70612-010)