FDA.reportPublic FDA data

MAGSOOTHIUM CBD HOMEOPATHIC PAIN RELIEVER SPRAY

Manufacturer
RENU LABORATORIES, INC.
Effective date
2022-01-13
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:17:12

Label at a glance#

ProductMagsoothium CBD Body
Active ingredientHAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, MAGNESIUM SULFATE, UNSPECIFIED, ARNICA MONTANA FLOWER
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

Arnica Montana (Arnica) 1X................................................Pain, inflammation

Hamamelis Virginiana (Witch Hazel) 1X ............................Pain, Fatigue

Magnesia Sulphurica (Magnesium Sulfate) 1X ..................Pain

INDICATIONS & USAGE SECTION

Uses:

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

WARNINGS SECTION

Warnings:

For external use only

  • Do not use on broken skin

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.

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 help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions: adults and children 12 years of age and older, apply to affected area no more than 10 times a day as needed for pain

children under 12 years of age: do not use, consult a doctor.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Cannabis Sativa (Hemp) Seed Oil (Broad Spectrum) and Hemp Derived Cannabidiol (CBD) Extract, Deionized Water, Fragrance, Hydroxyethyl Cellulose, Isopropyl Alcohol, Mentha piperita (Peppermint) Oil, Menthol, Polysorbate 20, Potassium Sorbate, Sodium Benzoate.

OTC - QUESTIONS SECTION

888.228.9828

Manufactured for

UbU Elements Inc.

Forty Fort, PA 18704

www.magsoothium.com

BOTTLE LABEL

REFERENCES SECTION

Bottle LabelBottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

4.0 oz. CBD Spray label

4.0 oz. CBD Spray label4.0 oz. CBD Spray label

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76348-42476348-424-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
ISOPROPYL ALCOHOLND2M416302IACT
MENTHOLL7T10EIP3AIACT
CANNABIS SATIVA SEED OIL69VJ1LPN1SIACT
CANNABIDIOL19GBJ60SN5IACT
PEPPERMINT OILAV092KU4JHIACT
LOBELIA INFLATA9PP1T3TC5UIACT
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARKT7S323PKJSACTIB
SODIUM BENZOATEOJ245FE5EUIACT
WATER059QF0KO0RIACT
MAGNESIUM SULFATE, UNSPECIFIEDDE08037SABACTIB
GRAPEFRUITO82C39RR8CIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZACTIB
POTASSIUM SORBATE1VPU26JZZ4IACT
POLYSORBATE 806OZP39ZG8HIACT

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
07a085aa-adcb-4648-e063-6294a90a6cb7888c4158-8b13-aa4f-e053-2a95a90a14fd2023-10-13WarningsExact identifier
spl set id: 888c4158-8b13-aa4f-e053-2a95a90a14fd

Reported adverse events (FAERS/openFDA)#

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