MagneLeaf Cooling with CBD by M J Green Enterprises, INC

MagneLeaf Cooling with CBD by

Drug Labeling and Warnings

MagneLeaf Cooling with CBD by is a Homeopathic medication manufactured, distributed, or labeled by M J Green Enterprises, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

MAGNELEAF COOLING WITH CBD- magnesium chloride, menthol, arnica montana cream 
M J Green Enterprises, INC

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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Active Ingredients

Arnica Montana 1%

Methyl Salicylate >1%

Menthol >1%

Purpose:

Topical Analgesic

Uses

Temporary relief of aches and pains associated with: Arthritis, Carpal Tunnel, Swelling, Sprains, Bruising, Inflammation

Warnings

For external use only.

When Using This Product:

Avoid contact with eyes, avoid use on deep wounds, avoid if you are allergic to listed ingredients.

Stop Use and consult a doctor if:

Condition worsens, Symptoms last for more than 7 days, condition clears up but occurs again in a few days, rash or irritation occurs.

If Pregnant or Breast-feeding:

Consult a health profesional before use.

Dosage

Apply to affected area 1 to 4 times daily, or as needed.

Keep Out of Reach of Children

Keep out of reach of children

Other Information

Store at 66-92 Degrees Fahrenheit. Avoid direct sunlight.

Inactive Ingredients

Shea Butter, Jojoba Oil, Beeswax, Coconut Oil, Water, Vitamin E oil, Magnesium Chloride, Cannabidiol Oil, Maranta Arrundinacea Root Powder

6 ounce jar label

6 ounce lid label

MAGNELEAF COOLING WITH CBD 
magnesium chloride, menthol, arnica montana cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82900-110
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	0.57 g  in 170.96 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.28 g  in 170.96 g
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	1.7 g  in 170.96 g

Inactive Ingredients
Ingredient Name	Strength
CANNABIDIOL (UNII: 19GBJ60SN5)	1.42 g  in 170.96 g
WATER (UNII: 059QF0KO0R)	8.79 g  in 170.96 g
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)	4.25 g  in 170.96 g
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)	6.52 g  in 170.96 g
MARANTA ARUNDINACEA ROOT (UNII: FVN346W31A)	0.57 g  in 170.96 g
SHEA BUTTER (UNII: K49155WL9Y)	55 g  in 170.96 g
PEG-8 BEESWAX (UNII: 3C1QUF1TIR)	18.43 g  in 170.96 g
COCONUT OIL (UNII: Q9L0O73W7L)	18.43 g  in 170.96 g
JOJOBA OIL (UNII: 724GKU717M)	55 g  in 170.96 g

Product Characteristics
Color	white (Cream)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82900-110-13	170.96 g in 1 JAR; Type 0: Not a Combination Product	01/02/2023	09/19/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		01/02/2023	09/19/2023

Labeler - M J Green Enterprises, INC (099497973)

Establishment
Name	Address	ID/FEI	Business Operations
M J Green Enterprises, INC		099497973	manufacture(82900-110)

Revised: 9/2023

Document Id: 05a42e3e-8a67-6112-e063-6394a90ab85c

34390-5

Set id: e82e7f88-0f7b-91b6-e053-2995a90a070f

Version: 2

Effective Time: 20230918