FDA.reportPublic FDA data

Magsoothium CBD Cooling Formula

Manufacturer
Renu Laboratories, Inc.
Effective date
2022-01-13
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 22:17:12

Label at a glance#

ProductMagsoothium CBD Cooling Formula
Active ingredientARNICA MONTANA, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, MAGNESIUM SULFATE HEPTAHYDRATE
Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Arnica Montana (Arnica) 1X

Hamamelis Virginiana (Witch Hazel) 1X

Magnesia Sulphurica (Magnesium Sulfate) 1X

OTC - PURPOSE SECTION

Purpose

Pain, inflammation

Pain, Fatigue

Pain

INDICATIONS & USAGE SECTION

Uses

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

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.

WARNINGS SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical helpor contact a poison control center right away

OTC - QUESTIONS SECTION

Questions or Comments

888 228 9828

INACTIVE INGREDIENT SECTION

Inactive ingredients

Cannabis Sativa (Hemp) Seed Oil (Broad Spectrum) and Hemp Derived Cannabidiol 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.

OTC - STOP USE SECTION

Stop and ask a doctor if

Pain Persists for more than 5 days

If pain, redness, or swelling worsens
if new symptoms occur

DOSAGE & ADMINISTRATION SECTION

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: Consulta a doctor

PACKAGE LABELS

REFERENCES SECTION

Magsoothium Cool Cream Side.jpg

SIDE LABEL FOR PRODUCTSIDE LABEL FOR PRODUCTTOP LABEL FOR PRODUCT

TOP LABEL FOR PRODUCTTOP LABEL FOR PRODUCT

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Magsoothium Cool Cream Top LabelMagsoothium Cool Cream Top Label[Magsoothium Cool Cream label] and Magsoothium Cool Cream Top Label

Magsoothium Cool Cream Side.jpg

Round Label Magsoothium Cooling (2).jpg

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76348-42376348-423-01, 76348-423-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
CANNABIDIOL19GBJ60SN5IACT
GRAPEFRUITO82C39RR8CIACT
LOBELIA INFLATA9PP1T3TC5UIACT
PEG-100 STEARATEYD01N1999RIACT
SHEA BUTTERK49155WL9YIACT
MANGIFERA INDICA SEED BUTTER4OXD9M35X2IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
PHENOXYETHANOLHIE492ZZ3TIACT
LAURETH-7Z95S6G8201IACT
OLIVE OIL6UYK2W1W1EIACT
COCONUT OILQ9L0O73W7LIACT
CANNABIS SATIVA SEED OIL69VJ1LPN1SIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
STEARIC ACID4ELV7Z65APIACT
WHITE WAX7G1J5DA97FIACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
CORN OIL8470G57WFMIACT
MENTHOLL7T10EIP3AIACT
POLYACRYLAMIDE (10000 MW)E2KR9C9V2IIACT
PEPPERMINT OILAV092KU4JHIACT
WATER059QF0KO0RIACT
MAGNESIUM CHLORIDE02F3473H9OIACT
ARNICA MONTANAO80TY208ZWACTIB
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARKT7S323PKJSACTIB
MAGNESIUM SULFATE HEPTAHYDRATESK47B8698TACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f8c08cf8-d34c-a206-e053-6394a90a975b88655a85-866a-3b75-e053-2995a90a79682023-04-07WarningsExact identifier
spl set id: 88655a85-866a-3b75-e053-2995a90a7968

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.