Label: MARS WELLNESS MG PLUS PAIN CREAM- arnica, magnesium sulphurica, witch hazel cream

  • NDC Code(s): 76348-800-04
  • 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 September 30, 2021

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  • ACTIVE INGREDIENT

    Active Ingredients

    Arnica Montana 1 X

    Hamamelis Virginiana 1X

    Magnesia Sulphurica 1X

  • Warnings

    For external use only. Do not use on broken skin or open wounds.

    Keep out of reach of children. If swallowed get medical help or contact a Poison Control center right away.

  • PURPOSE

    Arnica Montana Pain, Inflammation

    Hamamelis Virginiana Pain, Fatigue

    Magnesia Sulphurica Pain

  • DOSAGE & ADMINISTRATION

    Directions

    Adults and children over the age of 2 years old: Apply generously with gentle rubbing to the affected area 2 - 3 times daily or as needed.

    Children less than 2 years of age: Consult a doctor.

  • INACTIVE INGREDIENT

    Butyrospermum Parkii (Shea) Butter, Cetearyl Alcohol, C-13-14 Isoparaffin, Cetearyl Glucoside, Cocos Nucifera (Coconut) Oil, Deionized Water, Emulsifying Wax, Fragrance, Glyceryl Stearate, Laureth-7, Lobelia Inflata (Lobelia) Extract, Mangifera Indica (Mango) Seed Butter, Mentha piperita (Peppermint) Leaf Oil, Olea europaea (Olive) Oil, Olus (Vegetable) Oil, PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Stearic Acid.

  • Uses

    for temporary relief of minor aches and pains asssociated with

    arthritis

    simple backache

    muscle strains

    sprains

    bruises

  • QUESTIONS OR COMMENTS

    MARS Wellness

    1950 Rutgers Univ Blvd

    Lakewood NJ 08701

    888-575-6277

    info@marswellness.com

    www.marsmedsupply.com

  • DO NOT USE

    Do not use on broken skin or open wounds.

  • STOP USE

    Stop and ask a doctor if

    • Pain persists for more than 5 days
    • if pain, redness, or swelling worsens
    • If new symptoms occur.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • PRINCIPAL DISPLAY PANEL

    MG PLUS LABELSpPRODUCT LABELS TOP AND SIDE

  • INGREDIENTS AND APPEARANCE
    MARS WELLNESS MG PLUS PAIN CREAM 
    arnica, magnesium sulphurica, witch hazel cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76348-800
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA1.12 g  in 112 g
    MAGNESIUM SULFATE ANHYDROUS (UNII: ML30MJ2U7I) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM SULFATE ANHYDROUS2.24 g  in 112 g
    WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL1.12 g  in 112 g
    Inactive Ingredients
    Ingredient NameStrength
    LOBELIA INFLATA LEAF (UNII: 7QFT17RLRG)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MENTHOL (UNII: L7T10EIP3A)  
    WATER (UNII: 059QF0KO0R)  
    POLYETHYLENE GLYCOL 4500 (UNII: TVH7653921)  
    CORN OIL (UNII: 8470G57WFM)  
    MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    GRAPEFRUIT OIL (UNII: YR377U58W9)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    LAURETH-7 (UNII: Z95S6G8201)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    CHAMOMILE (UNII: FGL3685T2X)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    MALVA SYLVESTRIS FLOWERING TOP (UNII: X1U1U0N90J)  
    ASIAN GINSENG (UNII: CUQ3A77YXI)  
    COMFREY LEAF (UNII: DG4F8T839X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76348-800-04112 g in 1 JAR; Type 0: Not a Combination Product09/14/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/10/2021
    Labeler - Renu Laboratories, Inc. (945739449)
    Establishment
    NameAddressID/FEIBusiness Operations
    Renu Laboratories, Inc.945739449manufacture(76348-800)
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