Label: MAGSOOTHIUM CBD BODY LAVENDER- menthol cream
- NDC Code(s): 83262-003-01
- Packager: Ubu/Elements, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated April 19, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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WARNINGS
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 toipcal 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.
- DOSAGE & ADMINISTRATION
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INACTIVE INGREDIENT
Inactive Ingredients: Water, Cannabis Sativa Seed Oil,Cocos Nucifera (Coconut) Oil, Olea Europaea (Olive) Fruit Oil, Glyceryl Stearate, Glycerin, Polyglyceryl-2 Stearate, PEG-100 Stearate, Mangifera Indica (Mango) Seed Butter, Stearic Acid, Palmitic Acid, Stearyl Alcohol, Magnesium Sulfate, Lavandula Angustifolia (Lavender) Oil, Phenoxyethanol, Arnica Montana Flower Extract, Ethylhexylglycerin, Xanthan Gum, Hamamelis Virginiana (Witch Hazel) Bark/Leaf/Twig Extract, Magnesium Chloride, Tocopheryl Acetate, Cetearyl Alcohol, Polysorbate 60, Phytomelatonin, Propanediol, 1,2-Hexanediol, Hypericum Perforatum L. Extract, Caprylhydroxamic Acid.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MAGSOOTHIUM CBD BODY LAVENDER
menthol creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83262-003 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 5 g in 100 mL Inactive Ingredients Ingredient Name Strength COCONUT OIL (UNII: Q9L0O73W7L) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) POLYGLYCERYL-2 STEARATE (UNII: 253MC0P0YV) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) PHENOXYETHANOL (UNII: HIE492ZZ3T) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) POLYSORBATE 60 (UNII: CAL22UVI4M) HYPERICUM PERFORATUM WHOLE (UNII: XK4IUX8MNB) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) WATER (UNII: 059QF0KO0R) CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S) STEARIC ACID (UNII: 4ELV7Z65AP) PALMITIC ACID (UNII: 2V16EO95H1) PEG-100 STEARATE (UNII: YD01N1999R) MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2) LAVENDER OIL (UNII: ZBP1YXW0H8) XANTHAN GUM (UNII: TTV12P4NEE) HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) OLIVE OIL (UNII: 6UYK2W1W1E) PROPANEDIOL (UNII: 5965N8W85T) CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83262-003-01 112 mL in 1 JAR; Type 0: Not a Combination Product 04/21/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 04/21/2023 Labeler - Ubu/Elements, Inc. (117378343)
