PS- menthol gel 
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.

----------

CBD Power Gel Professional

CBD Power Gel Professional

CBD Power Gel P

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)

Revised: 1/2020
Document Id: 9ce98dc6-3354-52a5-e053-2995a90a9a9c
Set id: 9ce98dc6-3353-52a5-e053-2995a90a9a9c
Version: 1
Effective Time: 20200124
 
New Leaf Pharmaceutical, LLC