MAGNESIUM PURE COOLING CREAM

Magsoothium Pure Formula by

Drug Labeling and Warnings

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

Drug Details [pdf]

MAGSOOTHIUM PURE FORMULA- arnica, witch hazel, magnesium cream 
Renu Laboratories, 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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MAGNESIUM PURE COOLING CREAM

Purpose

Pain, inflammation

Pain, Fatigue

Pain

Uses

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

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

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

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: Butyrospermum Parkii (Shea) Butter, C13-14 Isoparaffin, Cetearyl Alcohol, Cetearyl Glucoside, Cocos Nucifera (Coconut) Oil, Deionized Water, Emulsifying Wax, Fragrance, Glyceryl Stearate, Laureth-7, 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, Polyacrylamide, Stearic Acid.

Questions or Comments

1 888 228 9828

Manufactured for

UbU Elements Inc.

Forty Fort, PA 18704

www.magsoothium.com

Arnica Montana

Hamamelis Virginiana

Magnesia Sulphurica

MAGSOOTHIUM SIDE AND TOP JAR LABELS

MAGSOOTHIUM PURE FORMULA 
arnica, witch hazel, magnesium cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76348-431
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM SULFATE, UNSPECIFIED	11.2 g  in 112 g
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	1.12 g  in 112 g
WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34)	WITCH HAZEL	1.12 g  in 112 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76348-431-04	112 g in 1 JAR; Type 0: Not a Combination Product	07/30/2020	10/25/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		07/29/2020	10/25/2022

Labeler - Renu Laboratories, Inc. (945739449)

Establishment
Name	Address	ID/FEI	Business Operations
Renu Laboratories, Inc.		945739449	manufacture(76348-431)

Revised: 10/2023

Document Id: 07a0a0b6-90a6-8cbf-e063-6394a90a49fb

34390-5

Set id: ababe9d9-de35-ae40-e053-2a95a90a63ce

Version: 3

Effective Time: 20231013