Otc - Active Ingredient
Arnica Montana 1X
Hamamelis Virginiana 1X
Magnesium Sulfurica 1X
Mars Wellness Magnesium Spray
FDA Label NDC 76348-810
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Renu Laboratories, Llc for the product Mars Wellness Magnesium (NDC 76348-810). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Inflammation
Pain, Fatigue
Pain
Indications & Usage
For the temporary relief of pain associated with minor skin procedures
Warnings
For external use only.
Otc - Do Not Use
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
Otc - When Using
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
Otc - Stop Use
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.
Otc - 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.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children and pets.
Dosage & Administration
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
Recent Major Changes
No major changes - this is a new listing
Inactive Ingredient
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
Storage And Handling
Store at 20 - 25 degrees C (68 - 77 degrees F)
Otc - Questions
Questions ?
888-575-6277
Package Label.Principal Display Panel
Bottle label
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