Label: MAG 5 PT WARMING FORMULA- menthol cream

  • NDC Code(s): 76348-511-04, 76348-511-05
  • Packager: RENU LABORATORIES, INC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated February 5, 2023

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  • ACTIVE INGREDIENT

    Menthol 5%

  • PURPOSE

    Topical Analgesic

  • INDICATIONS & USAGE

    For temporary relief of minor aches and pains of muscles and joints associated with deep muscle therapy treatments.

  • WARNINGS

    For external use only

  • WHEN USING

  • WHEN USING

    Do not bandage tightly

    • avoid contact with eyes
    • do not apply to wounds or damaged skin
    • do not use with heating pads or other heating devices.
  • STOP USE

    Stop use and ask a doctor if

    • Condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days
  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • adults and children 12 years of age and older, apply to affected area no more than 10 times a day or as directed by your physical or occupational therapist
    • children under 12 years of age, do not use, consult a doctor.
  • INACTIVE INGREDIENT

    Arnica Montana (Arnica) Flower Extract, Butyrospermum Parkii (Shea) Butter, Cannabis Sativa (Hemp) Seed Oil, Cetearyl Alcohol, Cetearyl Glucoside, Cocos Nucifera (Coconut) Oil, Deionized Water, Emulsifying Wax, Fragrance, Hamamelis Virginiana (Witch Hazel), Hemp Derived Cannabidiol (CBD) Extract, Laureth-7, Lobelia Inflata (Lobelia) Extract, Magnesium Chloride, Magnesium Citrate, Magnesium Gluconate, Magnesium Myristate, Magnesium Sulfate, Mangifera Indica (Mango) Seed Buter, Mentha Piperita (Peppermint) Oil, Olea Europaea (Olive) Oil, Olus Oil (Vegetable), Phenoxyethanol, Polyacrylamide C13-14 Isoparaffin, Xanthan Gum

  • PRINCIPAL DISPLAY PANEL

    Mag5PT label

    Mag5PT Warming Box

  • MAG 5 PT JAR LABEL AND BOX

    JAR LABELMAG 5 PT WARMING BOX

  • INGREDIENTS AND APPEARANCE
    MAG 5 PT WARMING FORMULA 
    menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76348-511
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5.6 g  in 112 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    WITCH HAZEL (UNII: 101I4J0U34)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    LAURETH-7 (UNII: Z95S6G8201)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    HIPPOPHAE RHAMNOIDES SEED OIL (UNII: T53SBG6741)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    LOBELIA INFLATA LEAF (UNII: 7QFT17RLRG)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    MAGNESIUM MYRISTATE (UNII: Z1917F0578)  
    TABASCO PEPPER (UNII: J1M3NA843L)  
    MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
    CORN OIL (UNII: 8470G57WFM)  
    MAGNESIUM OROTATE (UNII: GI96W46M5A)  
    CANNABIDIOL (UNII: 19GBJ60SN5)  
    MAGNESIUM GLUCONATE (UNII: T42NAD2KHC)  
    HIPPOPHAE RHAMNOIDES FRUIT OIL (UNII: TA4JCF9S1J)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
    POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76348-511-051 in 1 BOX03/19/2019
    1NDC:76348-511-04112 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/19/2019
    Labeler - RENU LABORATORIES, INC. (945739449)
    Establishment
    NameAddressID/FEIBusiness Operations
    RENU LABORATORIES, INC.945739449manufacture(76348-511)
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