Prof: Package Insert and Label Information

PROF- menthol, unspecified form 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.

CBD Power Spray Professional

CBD Power Spray Prof

PROF
mentholxs spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:71798-004
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL, UNSPECIFIED FORM (MENTHOL, UNSPECIFIED FORM) MENTHOL, UNSPECIFIED FORM 10.5 g in 10.5 mL
Inactive Ingredients
Ingredient Name Strength
CALENDULA OFFICINALIS FLOWER
ARNICA MONTANA FLOWER
CAPSICUM ANNUUM WHOLE
.ALPHA.-TOCOPHEROL ACETATE
WILLOW BARK
PEPPERMINT OIL (PEPPERMINT)
CANNABIDIOL
EMU OIL
METHYL SALICYLATE
Product Characteristics
Color white (Solution) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71798-004-03 88.7 mL in 1 CAN None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 10/01/2019
Labeler — New Leaf Pharmaceutical, LLC (080792350)
Establishment
Name Address ID/FEI Operations
New Leaf Pharmaceuticals, LLC 080792350 manufacture (71798-004)

Revised: 10/2019 New Leaf Pharmaceutical, LLC

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