MAGSOOTHIUM BODY COOLING FORMULA- menthol 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 Cooling Formula

Active Ingredient

Menthol USP 5.0%

Purpose
Topical Analgesic

Uses Temporary relieves minor aches and pains associated with

  • Sore muscles and joints
  • arthritis
  • backache
  • muscle strains
  • sprains
  • bruises

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

  • Do not bandage or cover the area being treated
  • Do not apply ice or heating pad in conjunction with this product.
  • Do not use with any medical device or other device
  • Do not combine with any other topical treatment
  • Avoid contact with eyes or mucous membrane
  • Do not apply to wounds or damaged skin

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

  • repeat as necessary but do not apply more than 4 times daily

Children under 2 years of age Consult a physician

Inactive Ingredients Water, Cocos Nucifera (Coconut) Oil, Cannabis Sativa Seed Oil, Olea Europaea (Olive) Fruit Oil, Glyceryl Stearate, Glycerin, Polyglyceryl-2 Stearate, PEG-100 Stearate, Cetearyl Acohol, Mangifera indica (Mango) Seed Butter, Stearyl Alcohol, Magnesium Sulfate, Mentha Piperita (Peppermint) Oil, Alcohol Denat., Phenoxyethanol,

Ethylhexylglycerin, Xanthan Gum, Hamamelis Virginiana (Witch Hazel) Bark/Leaf/Twig Extract, Arnica Montana Flower Extract, Magnesium Chloride, Polysorbate 60

Homeopathic Pain Reliever

Magsoothium CBD Cooling Formula

Magsoothium Body Cream

Helps relieve minor aches & pains

Net Contents: 4 oz (112 ml)

Cooling Jar

MAGSOOTHIUM BODY COOLING FORMULA 
menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83262-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
WATER (UNII: 059QF0KO0R)  
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
COCONUT OIL (UNII: Q9L0O73W7L)  
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)  
XANTHAN GUM (UNII: TTV12P4NEE)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83262-002-01112 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
 
Ubu/Elements, Inc.