Label: MARS WELLNESS MAGNESIUM- menthol spray

  • NDC Code(s): 76348-810-04
  • Packager: RENU LABORATORIES, INC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated March 23, 2022

If you are a consumer or patient please visit this version.

View All Sections
  • ACTIVE INGREDIENT

    Arnica Montana 1X

    Hamamelis Virginiana 1X

    Magnesium Sulfurica 1X

  • PURPOSE

    Inflammation

    Pain, Fatigue

    Pain

  • INDICATIONS & USAGE

    For the temporary relief of pain associated with minor skin procedures

  • WARNINGS

    For external use only.

  • 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
  • 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
  • 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.
  • 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.

  • 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
  • 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)

  • QUESTIONS

    Questions ?

    888-575-6277

  • PRINCIPAL DISPLAY PANEL

    Bottle label

    Mg SPRAY LABEL

  • INGREDIENTS AND APPEARANCE
    MARS WELLNESS MAGNESIUM 
    menthol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76348-810
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL0.11 g  in 112 g
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA1.12 g  in 112 g
    MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM SULFATE, UNSPECIFIED0.12 g  in 112 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    MENTHOL (UNII: L7T10EIP3A)  
    CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    LOBELIA INFLATA (UNII: 9PP1T3TC5U)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    COMFREY LEAF (UNII: DG4F8T839X)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    CHAMOMILE (UNII: FGL3685T2X)  
    PANAX GINSENG FLOWER (UNII: 3V5S2B524J)  
    MALVA SYLVESTRIS FLOWER (UNII: 12X9JI52BS)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76348-810-04112 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/23/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/23/2022
    Labeler - RENU LABORATORIES, INC. (945739449)
    Establishment
    NameAddressID/FEIBusiness Operations
    RENU LABORATORIES, INC.945739449manufacture(76348-810)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!