Label: RS- menthol spray

  • 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 October 7, 2019

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  • DOSAGE & ADMINISTRATION

  • WARNINGS

  • INACTIVE INGREDIENT

  • INDICATIONS & USAGE

  • ACTIVE INGREDIENT

  • PURPOSE

  • KEEP OUT OF REACH OF CHILDREN

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  • INGREDIENTS AND APPEARANCE
    RS 
    menthol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71798-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM4 g  in 4 mL
    Inactive Ingredients
    Ingredient NameStrength
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    WILLOW BARK (UNII: S883J9JDYX)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    CANNABIDIOL (UNII: 19GBJ60SN5)  
    EMU OIL (UNII: 344821WD61)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    CAPSICUM ANNUUM WHOLE (UNII: 7FKZ3QQQ1F)  
    Product Characteristics
    Colorwhite (Solution) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71798-003-0388.7 mL in 1 CAN; Type 0: Not a Combination Product10/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34810/01/2019
    Labeler - New Leaf Pharmaceutical, LLC (080792350)
    Establishment
    NameAddressID/FEIBusiness Operations
    New Leaf Pharmaceutical, LLC080792350manufacture(71798-003)