Purpose
The purpose of this product is to reduce pain.
Magnesoothe Magnesium Oil
FDA Label NDC 78735-1000
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Mg12, Lp for the product Magnesoothe Magnesium Oil (NDC 78735-1000). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding purpose, how to apply, dosage, ingredients, warnings, keep out of reach of children, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
How To Apply
Rub 5 ml of product (one pump) thoroughly into epidermis.
Dosage
7.5 grams (or .075ml) grams of magnesium per pump.
Ingredients
No active Ingredients
60 ml Magnesium Chloride per 100 ml
40 ml Water per 100 ml
Warnings
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
See warnings section
Package Label.Principal Display Panel
118 ml per bottle 78735-1000-4
* Please review the disclaimer below.
