NDC 78735-1000 Magnesoothe Magnesium Oil

Magnesium Oil

NDC Product Code 78735-1000

NDC 78735-1000-4

Package Description: 118 g in 1 BOTTLE, PUMP

NDC Product Information

Magnesoothe Magnesium Oil with NDC 78735-1000 is a a human over the counter drug product labeled by Mg12, Lp. The generic name of Magnesoothe Magnesium Oil is magnesium oil. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Mg12, Lp

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Magnesoothe Magnesium Oil Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • ISOPROPYL ALCOHOL 10 g/100g

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
  • WATER (UNII: 059QF0KO0R)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Mg12, Lp
Labeler Code: 78735
Marketing Category: UNAPPROVED DRUG OTHER - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 10-18-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Magnesoothe Magnesium Oil Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

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

60 ml Magnesium Chloride per 100 ml40 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

* Please review the disclaimer below.