MAGSOOTHIUM CBD COOLING FORMULA- arnica montana, hamamelis v, magnesia sulphurica cream

Magsoothium CBD Cooling Formula by

Drug Labeling and Warnings

Magsoothium CBD Cooling Formula by is a Homeopathic medication manufactured, distributed, or labeled by Renu Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients

Arnica Montana (Arnica) 1X

Hamamelis Virginiana (Witch Hazel) 1X

Magnesia Sulphurica (Magnesium Sulfate) 1X

PURPOSE

Purpose

Pain, inflammation

Pain, Fatigue

Pain

INDICATIONS & USAGE

Uses

Natural temporary relief for aches, pains and inflammation from minor injuries, overexertion and fatigue

Directions

Adults and children over the age of 2 years old: Apply generously with gentle rubbing to the affected area 2-3 times daily or as needed.

Children less than 2 years of age: Consult a doctor.

WARNINGS

Warnings

For external use only. Do not use on broken skin or open wounds.

Stop and ask a doctor if

Pain Persists for more than 5 days

• If pain, redness, or swelling worsens
• if new symptoms occur

PREGNANCY OR BREAST FEEDING

If pregnant or Breast-feeding, ask a health professional before use

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical helpor contact a poison control center right away

QUESTIONS

Questions or Comments

888 228 9828

INACTIVE INGREDIENT

Inactive ingredients

Cannabis Sativa (Hemp) Seed Oil (Broad Spectrum) and Hemp Derived Cannabidiol Extract, Cetearyl Alcohol, Cetearyl Glucoside, Cocos Nucifera (Coconut) Oil, Deionized Water, Emulsifying Wax, Fragrance, Glyceryl Stearate, Lobelia Inflata Extract, Magnesium Chloride, Mangifera Indica (Mango) Seed Butter, Mentha Piperita (Peppermint) Oil, Menthol, Olea Europaea (Olive Oil), Olus (Vegetable) Oil, PEG-100 Stearate, Phenoxyethanol, Stearic Acid.

STOP USE

Stop and ask a doctor if

Pain Persists for more than 5 days

If pain, redness, or swelling worsens
if new symptoms occur

DOSAGE & ADMINISTRATION

Directions

Adults and children over the age of 2 years old:

Apply generously with

gentle rubbing to the affected area 2 - 3 times daily or as needed.

Children less than 2 years of age: Consulta a doctor

PACKAGE LABELS

Magsoothium Cool Cream Side.jpg

TOP LABEL FOR PRODUCT

PRINCIPAL DISPLAY PANEL

[Magsoothium Cool Cream label] and Magsoothium Cool Cream Top Label

Magsoothium Cool Cream Side.jpg

Round Label Magsoothium Cooling (2).jpg

INGREDIENTS AND APPEARANCE

MAGSOOTHIUM CBD COOLING FORMULA 
arnica montana, hamamelis v, magnesia sulphurica cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76348-423
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	1.12 g  in 112 g
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS) (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - UNII:T7S323PKJS)	HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK	1.12 g  in 112 g
MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM SULFATE HEPTAHYDRATE	0.224 g  in 112 g

Inactive Ingredients
Ingredient Name	Strength
CANNABIDIOL (UNII: 19GBJ60SN5)
GRAPEFRUIT (UNII: O82C39RR8C)
LOBELIA INFLATA (UNII: 9PP1T3TC5U)
PEG-100 STEARATE (UNII: YD01N1999R)
SHEA BUTTER (UNII: K49155WL9Y)
MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
LAURETH-7 (UNII: Z95S6G8201)
OLIVE OIL (UNII: 6UYK2W1W1E)
COCONUT OIL (UNII: Q9L0O73W7L)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
STEARIC ACID (UNII: 4ELV7Z65AP)
WHITE WAX (UNII: 7G1J5DA97F)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CORN OIL (UNII: 8470G57WFM)
MENTHOL (UNII: L7T10EIP3A)
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
PEPPERMINT OIL (UNII: AV092KU4JH)
WATER (UNII: 059QF0KO0R)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76348-423-02	1 in 1 BOX	04/03/2017
1	NDC: 76348-423-01	112 g in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		04/03/2017

Labeler - Renu Laboratories, Inc. (945739449)

Establishment
Name	Address	ID/FEI	Business Operations
Renu Laboratories, Inc.		945739449	manufacture(76348-423)