Label: MAG 5 PT COOLING FORMULA RECOVERY CREAM- menthol cream

  • NDC Code(s): 76348-510-16
  • 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

  • WARNINGS

    For external use only

  • 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 heatng 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 three times a day or as directed by your physical or occupational therapist

    • children under 12 years of age: consult your physical or occupational therapist.
  • INACTIVE INGREDIENT

    Arnica Montana (Arnica) Flower Extract, Butyrospermum Parkii (Shea Butter), Cannabis Sativa (Hemp) Seed Oil and Hemp-Derived Cannabidiol (CBD) Extract, Cetearyl Alcohol, Cetearyl Glucoside, Citrus Paradisi (Grapefruit) Extract, Cocos Nucifera (Coconut) Oil, C13-14 Isoparaffin, Deionized Water, Emulsifying Wax, Hamamelis Virginiana (Witch Hazel), Hippophae Rhamnoides (Sea Berry) Fruit Oil, Hippophae Rhamnoides (Sea Berry) Seed Oil, Laureth-7, Lobelia Flower Extract, Magnesium Chloride, Magnesium Gluconate, Magnesium Myristate, Magnesium Orotate, Magnesium Sulfate, Mangifera Indica (Mango) Seed Butter, Mentha piperita (Peppermint) Leaf Oil, Olea Europaea (Olive) Oil, Olus Oil (vegetable), Phenoxyethanol, Polyacrylamide, Xanthan Gum

  • QUESTIONS

    Visit us on the web www.mag5pt.com

  • INDICATIONS & USAGE

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

  • MAG 5 PT 16.0 OZ. LABEL

    16 OZ. COOLING LABEL

  • INGREDIENTS AND APPEARANCE
    MAG 5 PT COOLING FORMULA RECOVERY CREAM 
    menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76348-510
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL22.7 g  in 454 g
    Inactive Ingredients
    Ingredient NameStrength
    CANNABIDIOL (UNII: 19GBJ60SN5)  
    MAGNESIUM OROTATE (UNII: GI96W46M5A)  
    MAGNESIUM GLUCONATE (UNII: T42NAD2KHC)  
    HIPPOPHAE RHAMNOIDES SEED OIL (UNII: T53SBG6741)  
    WITCH HAZEL (UNII: 101I4J0U34)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
    CORN OIL (UNII: 8470G57WFM)  
    POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
    LAURETH-7 (UNII: Z95S6G8201)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    LOBELIA INFLATA LEAF (UNII: 7QFT17RLRG)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    MAGNESIUM MYRISTATE (UNII: Z1917F0578)  
    HIPPOPHAE RHAMNOIDES FRUIT OIL (UNII: TA4JCF9S1J)  
    MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76348-510-16454 g in 1 JAR; Type 0: Not a Combination Product03/19/2019
    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(76348-510)
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