PS by New Leaf Pharmaceutical, LLC PS- menthol gel

PS by

Drug Labeling and Warnings

PS by is a Otc medication manufactured, distributed, or labeled by New Leaf Pharmaceutical, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

KEEP OUT OF REACH OF CHILDREN

PURPOSE

INDICATIONS & USAGE

INACTIVE INGREDIENT

WARNINGS

DOSAGE & ADMINISTRATION

CBD Power Gel Professional

INGREDIENTS AND APPEARANCE

PS 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71798-006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	10.5 g  in 10.5 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71798-006-03	88.7 mL in 1 TUBE; Type 0: Not a Combination Product	04/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	04/01/2020

Labeler - New Leaf Pharmaceutical, LLC (080792350)

Establishment
Name	Address	ID/FEI	Business Operations
New Leaf Pharmaceutical, LLC		080792350	manufacture(71798-006)