Label: ROOVEMAG MAGNESIUM SOOTHING WARMING CREAM- arnica montana, hamamelis virginiana, magnesia sulphurica cream

  • NDC Code(s): 76348-403-01
  • Packager: RENU LABORATORIES, INC.
  • Category: HUMAN OTC DRUG LABEL

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 February 8, 2023

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  • ACTIVE INGREDIENT

    Active ingredients
    Arnica Montana (Arnica) 1X
    Hamamelis Virginiana (Witch Hazel) 1X
    Magnesia Sulphurica (Magnesium Sulfate) 1X

  • Purpose

    Pain, inflammation

    Pain, Fatigue

    Pain

  • Uses

    Natural temporary relief for aches, pains and inflammation from minor injuries, overexertion and fatigue.

  • Warnings

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

    Stop and ask a doctor if

    Pain Persists for more than 5 days

    • If pain, redness, or swelling worsens
    • if new symptoms occur
      If pregnant or Breast-feeding, ask a health professional before use.

    Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or Breast-feeding, ask a health professional before use.

  • 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.

  • 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 ingredients

    Butyrospermum Parkii (Shea) Butter, C13-14 Isoparaffin, Capsicum Frutescens (Pepper) Fruit Extract, Cetearyl Alcohol, Cetearyl Glucoside, Deionized Water, Emulsifying Wax, Fragrance, Glycerin, Laureth-7, Lobelia Inflata Extract, Mangifera Indica (Mango) Seed Butter, Mentha piperita (Peppermint) Leaf Oil, Menthol, Olea Europaea (Olive) Fruit Oil, Phenoxyethanol, Polyacrylamide, Sodium Hyaluronate (Hyaluronic) Acid, Tripeptide Marine Collagen, Vaccinium Angustifolium (Blueberry) Fruit Extract, Vegetable Oil, Xanthan Gum.

  • Questions or Comments

    Questions or Comments

    Contact: contact@tijara.llc

    Tijara, LLC

    447 Broadway,

    2nd Floor Suite #1188

    New York, New York 10013,

    United States

  • Uses

    Natural temporary relief for aches, pains and inflammation from minor injuries, overexertion and fatigue.

    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.

  • ROOVEMAG Magnesium Soothing Cream 60 ml LABEL

    MULTI-LAYER LABEL FOR ROOVEMAG CREAM 60 ML

    Roove Warming Label

  • INGREDIENTS AND APPEARANCE
    ROOVEMAG MAGNESIUM SOOTHING WARMING CREAM 
    arnica montana, hamamelis virginiana, magnesia sulphurica cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76348-403
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS) (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - UNII:T7S323PKJS) HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK0.6 g  in 60 g
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA0.6 g  in 60 g
    MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM SULFATE HEPTAHYDRATE0.12 g  in 60 g
    Inactive Ingredients
    Ingredient NameStrength
    HYALURONIC ACID (UNII: S270N0TRQY)  
    MARINE COLLAGEN, SOLUBLE (UNII: 8JC99XGU4W)  
    GRAPEFRUIT (UNII: O82C39RR8C)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)  
    LAURETH-7 (UNII: Z95S6G8201)  
    CAPSICUM (UNII: 00UK7646FG)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    CORN OIL (UNII: 8470G57WFM)  
    WATER (UNII: 059QF0KO0R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)  
    LOBELIA INFLATA LEAF (UNII: 7QFT17RLRG)  
    MENTHOL (UNII: L7T10EIP3A)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    VACCINIUM ANGUSTIFOLIUM LEAF (UNII: B4L873GNG1)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76348-403-0160 g in 1 JAR; Type 0: Not a Combination Product04/19/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/01/2023
    Labeler - RENU LABORATORIES, INC. (945739449)
    Establishment
    NameAddressID/FEIBusiness Operations
    RENU LABORATORIES, INC.945739449manufacture(76348-403)
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