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Mars wellness magnesium - Medication Information

Product NDC Code 76348-810
Drug Name

Mars wellness magnesium

Type Brand
Pharm Class Calculi Dissolution Agent [EPC],
Increased Large Intestinal Motility [PE],
Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],
Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],
Magnesium Ion Exchange Activity [MoA],
Osmotic Activity [MoA],
Osmotic Laxative [EPC],
Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
Active Ingredients
Arnica montana 1.12 g/112g
Magnesium sulfate, unspecified .12 g/112g
Witch hazel .11 g/112g
Route TOPICAL
Dosage Form SPRAY
Labeler Name RENU LABORATORIES, INC.
Packages
Package NDC Code Description
76348-810-04 112 g in 1 bottle, spray (76348-810-04)
Check if available Online

Active ingredient

A list of the active, medicinal ingredients in the drug product.
Arnica Montana 1X Hamamelis Virginiana 1X Magnesium Sulfurica 1X

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
Directions adults and children over 12 years: apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period after applying, wash hands with soap and water children 12 years or younger, ask a doctor

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredients: Aloe Barbadensis (Aloe Vera) Leaf Extract, Deionized Water, Calendula Officinalis (Marigold) Flower Extract, Cannabis Sativa (Hemp) Seed Oil, Chamomilla Recutita (Matricaria) (Chamomile) Flower Extract, Fragrance, Glycerin, Isopropyl Alcohol, Lobelia Extract, Malva Sylvestris (Mallow) Flower Extract, Mentha piperita (Peppermint) Oil, Menthol, Panax Ginseng Root Extract, Polysorbate 80, Potassium Sorbate, Sodium Benzoate, Symphytum Officinale (Comfrey) Leaf Extract

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
For the temporary relief of pain associated with minor skin procedures

Purpose

Information about the drug product’s indications for use.
Inflammation Pain, Fatigue Pain

Spl product data elements

Usually a list of ingredients in a drug product.
MARS WELLNESS MAGNESIUM MENTHOL WATER PEPPERMINT OIL WITCH HAZEL WITCH HAZEL POLYSORBATE 80 MENTHOL CANNABIS SATIVA SEED OIL POTASSIUM SORBATE ISOPROPYL ALCOHOL ARNICA MONTANA ARNICA MONTANA SODIUM BENZOATE LOBELIA INFLATA MAGNESIUM SULFATE, UNSPECIFIED MAGNESIUM CATION ALOE VERA LEAF COMFREY LEAF CALENDULA OFFICINALIS FLOWER CHAMOMILE PANAX GINSENG FLOWER MALVA SYLVESTRIS FLOWER

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
Bottle label Mg SPRAY LABEL

Recent major changes

A list of the section(s) that contain substantive changes that have been approved by FDA in the product labeling. The headings and subheadings, if appropriate, affected by the change are listed together with each section’s identifying number and the month and year on which the change was incorporated in the labeling.
No major changes - this is a new listing

Do not use

Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.
Do Not Use on large areas of the body or on cut, irritated or swollen skin on puncture wounds for more than one week without consulting a doctor

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of reach of children and pets.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions ? 888-575-6277

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
Stop use and ask a doctor if Condition worsens redness is present Irritation develops symptoms persist for more than 7 days or clear up and occur again within a few days. you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied.

When using

Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.
When using this product Use only as directed. Read and follow all directions and warnings on this label. rare cases of serious burns have been reported with products of this type. Do not bandage or apply local heat (such as heating pads) to the area of use or use with a medicated patch avoid contact with eyes and mucous membranes a transient burning sensation may occur upon application but generally disappears in several days

Pregnancy or breast feeding

Pregnancy or Breast feeding
If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children and pets. If swallowed, get medical help or contact a poison control center right away. Keep out of reach of children and pets.

Storage and handling

Information about safe storage and handling of the drug product.
Store at 20 - 25 degrees C (68 - 77 degrees F)

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
For external use only.

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API