FDA.reportPublic FDA data

Magnesoothe Magnesium Oil

Manufacturer
Mg12, LP
Effective date
2020-10-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:31:58

Label at a glance#

ProductMagnesoothe Magnesium Oil
Active ingredientISOPROPYL ALCOHOL
Label structure8 sections

Label contents#

Full prescribing information#

Purpose

OTC - PURPOSE SECTION

The purpose of this product is to reduce pain.

How to Apply

INDICATIONS & USAGE SECTION

Rub 5 ml of product (one pump) thoroughly into epidermis.

Dosage

DOSAGE & ADMINISTRATION SECTION

7.5 grams (or .075ml) grams of magnesium per pump.

Ingredients

OTC - ACTIVE INGREDIENT SECTION

No active Ingredients

Ingredients

INACTIVE INGREDIENT SECTION

60 ml Magnesium Chloride per 100 ml

40 ml Water per 100 ml

Warnings

WARNINGS SECTION

Information on toxicological effects
Skin corrosion/irritation
Not applicible
Serious eye damage/irritation
Causes eye irritation.
Respiratory or skin sensitization
May cause an allergic skin reaction
Germ cell mutagenicity
Not applicible

Carcinogenicity
ACGIH: No component of this product present at levels greater than or equal to 0.1% is identified as a
carcinogen or potential carcinogen by ACGIH.
Reproductive toxicity
Not applicible
STOT-single exposure
Not applicible
STOT-repeated exposure
Not applicible
Aspiration hazard
May be harmful if swallowed and enters airways

_____________ More Infromation _____________

Canadian Domestic Substances List (DSL)
Chemical name: Magnesium chloride (MgCl2)
CAS: 7786-30-3
SARA 302 Components
No chemicals in this material are subject to the reporting requirements of SARA Title III, Section 302.
SARA 313 Components
This material does not contain any chemical components with known CAS numbers that exceed the
threshold (De Minimis) reporting levels established by SARA Title III, Section 313.
SARA 311/312 Hazards
No SARA Hazards
Massachusetts Right To Know Components
No components are subject to the Massachusetts Right to Know Act.

Pennsylvania Right To Know Components
Water
CAS-No. 7732-18-5
New Jersey Right To Know Components
Water
CAS-No. 7732-18-5
California Prop. 65 Components
This product does not contain any chemicals known to State of California to cause cancer, birth defects, or
any other reproductive harm.
Canadian Domestic Substances List (DSL)
Chemical name: Water
CAS: 7732-18-5

Keep Out of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

See warnings section

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

118 ml per bottle 78735-1000-4

Magnesoothe Oil LabelMagnesoothe Oil Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78735-1000-42022-01-28C16284748780-1d6a99b39-7cd6-a426-e053-dadaa90af4c2Magnesoothe Magnesium Oil

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78735-1000-4Magnesoothe Magnesium Oil118 g in 1 BOTTLE, PUMPLIQUID1181

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78735-1000MAGNESOOTHE MAGNESIUM OIL (MAGNESIUM OIL) LIQUID [MG12, LP]1Legacy NDC, 1 package rows20201019_b1fde18d-c700-a5fa-e053-2995a90a8c25.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78735-100078735-1000-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
MAGNESIUM CHLORIDE02F3473H9OIACT
ISOPROPYL ALCOHOLND2M416302ACTIB
WATER059QF0KO0RIACT

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
b1fde18d-c701-a5fa-e053-2995a90a8c25b1fde18d-c700-a5fa-e053-2995a90a8c252020-10-18WarningsExact identifier
spl id: b1fde18d-c701-a5fa-e053-2995a90a8c25
spl set id: b1fde18d-c700-a5fa-e053-2995a90a8c25

Reported adverse events (FAERS/openFDA)#

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