MAGSOOTHIUM WARMING FORMULA- arnica montana, hamamelis virginiana, magnesia sulphurica cream

MAGSOOTHIUM Warming Formula by

Drug Labeling and Warnings

MAGSOOTHIUM Warming 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

Pain, inflammation

Pain, Fatigue

Pain

Uses

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

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 help or contact a poison control center right away.

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.

Inactive ingredients

Cannabis Sativa (Hemp) Seed Oil and Hemp Derived Cannabidiol (CBD) Extract, Capsicum Frutescens (Pepper) Fruit 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

Questions or Comments

888 228 9828

www.magsoothium.com

Uses

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

Side label

Side Label:

LID ART

INGREDIENTS AND APPEARANCE

MAGSOOTHIUM WARMING FORMULA 
arnica montana, hamamelis virginiana, magnesia sulphurica cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76348-430
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	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
GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947)
WHITE WAX (UNII: 7G1J5DA97F)
STEARIC ACID (UNII: 4ELV7Z65AP)
COCONUT OIL (UNII: Q9L0O73W7L)
OLIVE OIL (UNII: 6UYK2W1W1E)
MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)
LAURETH-7 (UNII: Z95S6G8201)
SHEA BUTTER (UNII: K49155WL9Y)
PEPPERMINT OIL (UNII: AV092KU4JH)
CORN OIL (UNII: 8470G57WFM)
WATER (UNII: 059QF0KO0R)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)
LOBELIA INFLATA LEAF (UNII: 7QFT17RLRG)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
CANNABIDIOL (UNII: 19GBJ60SN5)
MENTHOL (UNII: L7T10EIP3A)
GRAPEFRUIT (UNII: O82C39RR8C)
CAPSICUM (UNII: 00UK7646FG)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76348-430-01	112 g in 1 JAR; Type 0: Not a Combination Product	06/20/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		06/03/2019

Labeler - RENU LABORATORIES, INC. (945739449)

Establishment
Name	Address	ID/FEI	Business Operations
RENU LABORATORIES, INC.		945739449	manufacture(76348-430)