Label: PS- menthol gel

  • 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.

Drug Label Information

Updated January 24, 2020

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  • ACTIVE INGREDIENT

  • KEEP OUT OF REACH OF CHILDREN

  • PURPOSE

  • INDICATIONS & USAGE

  • INACTIVE INGREDIENT

  • WARNINGS

  • DOSAGE & ADMINISTRATION

  • CBD Power Gel Professional

    CBD Power Gel P

  • INGREDIENTS AND APPEARANCE
    PS 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71798-006
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM10.5 g  in 10.5 mL
    Inactive Ingredients
    Ingredient NameStrength
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    ARNICA MONTANA FLOWER WATER (UNII: U7L2JP51PR)  
    WILLOW BARK (UNII: S883J9JDYX)  
    HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71798-006-0388.7 mL in 1 TUBE; Type 0: Not a Combination Product04/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/01/2020
    Labeler - New Leaf Pharmaceutical, LLC (080792350)
    Establishment
    NameAddressID/FEIBusiness Operations
    New Leaf Pharmaceutical, LLC080792350manufacture(71798-006)
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