Label: MAGNESOOTHE MAGNESIUM OIL- magnesium oil liquid

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated October 18, 2020

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Purpose

    The purpose of this product is to reduce pain.

  • 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

  • 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

  • PRINCIPAL DISPLAY PANEL

    118 ml per bottle 78735-1000-4

    Magnesoothe Oil Label

  • INGREDIENTS AND APPEARANCE
    MAGNESOOTHE MAGNESIUM OIL 
    magnesium oil liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78735-1000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O) 60 g  in 100 g
    WATER (UNII: 059QF0KO0R) 30 g  in 100 g
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78735-1000-4118 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product10/18/2020
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/18/2020
    Labeler - Mg12, LP (032170536)
    Establishment
    NameAddressID/FEIBusiness Operations
    Mg12, LP032170536manufacture(78735-1000)