RS- menthol spray 
New Leaf Pharmaceutical, LLC

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.

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CBD Power Spray

CBD Power Spray

CBD Power Spray

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)

Revised: 10/2019
Document Id: 9453c831-f696-1016-e053-2a95a90a26cd
Set id: 9453c831-f695-1016-e053-2a95a90a26cd
Version: 1
Effective Time: 20191007
 
New Leaf Pharmaceutical, LLC