MAGSOOTHIUM BODY- menthol, capsaicin cream 
Ubu/Elements, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Magsoothium Body Cream

Active Ingredient

Menthol USP 2.0%

Capsaicin 0.032%


Purpose
Topical Analgesic

Uses Temporary relieves minor aches and pains associated with

Keep out of reach of children. In case of accidental ingestion get medical help or contact a Poison Control Center immediately

Stop use and ask a doctor if Condition worsens or symptoms persist for more than 7 days or clear up and recur

Redness is present or irritation develops

Warnings For external use only

When using this product use only as directed

If pregnant or breast-feeding Ask a health professional before use

Directions - Adults and children 2 years of age and older

Apply directly onto affected area without the need to rub, massage or bandage

Children under 2 years of age Consult a physician

Inactive Ingredients Water, Cannabis Sativa Seed Oil, Olea Europaea (Olive) Fruit Oil, Cocos Nucifera (Coconut) Oil, Glycerin, Glyceryl Stearate, Polyglyceryl-2 Stearate, PEG-100 Stearate, Mangifera indica (Mango) Seed Butter, Palmitic Acid, Stearic Acid, Stearyl Alcohol, Magnesium Sulfate, Mentha Piperita (Peppermint) Oil, Phenoxyethanol, Capsicum Frutescens Fruit, Arnica Montana Flower Extract, Ethylhexylglycerin, Hamamelis Virginiana (Witch Hazel) Bark/Leaf/Twig Extract, Magnesium Chloride, Xanthan Gum, Tocopheryl Acetate, Polyglycerin-3, Glycine Soja (Soybean) Oil, Propanediol, Cetearyl Acohol, Polysorbate 60, 1,2-Hexanediol, Caprylhydroxamic Acid

Homeopathic Pain Reliever

Magsoothium CBD Warming Formula

Magsoothium Body Cream

Helps relieve minor aches & pains

Net Contents: 4 oz (112 ml)

jar label

MAGSOOTHIUM BODY 
menthol, capsaicin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83262-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.032 g  in 100 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
PROPANEDIOL (UNII: 5965N8W85T)  
COCONUT OIL (UNII: Q9L0O73W7L)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
PALMITIC ACID (UNII: 2V16EO95H1)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
SOYBEAN OIL (UNII: 241ATL177A)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
WATER (UNII: 059QF0KO0R)  
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)  
POLYGLYCERYL-2 STEARATE (UNII: 253MC0P0YV)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
PEG-100 STEARATE (UNII: YD01N1999R)  
TABASCO PEPPER (UNII: J1M3NA843L)  
XANTHAN GUM (UNII: TTV12P4NEE)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83262-001-01112 mL in 1 JAR; Type 0: Not a Combination Product02/01/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/01/2023
Labeler - Ubu/Elements, Inc. (117378343)

Revised: 3/2023
Document Id: f604d30c-b17d-ec01-e053-2a95a90aa304
Set id: f604d30c-b17c-ec01-e053-2a95a90aa304
Version: 1
Effective Time: 20230303
 
Ubu/Elements, Inc.