MAGNIFICENT MENTHOL WARMING CREAM (MENTHOL CREAM) CREAM [RENU LABORATORIES, INC.]

MAGNIFICENT MENTHOL WARMING CREAM (MENTHOL CREAM) CREAM [RENU LABORATORIES, INC.]
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NDC 76348-422-01, 76348-422-02
Set ID 8506740a-3f42-a49f-e053-2a91aa0a0ac0
Category HUMAN OTC DRUG LABEL
Packager RENU LABORATORIES, INC.
Generic Name
Product Class
Product Number
Application Number PART348
  • ACTIVE INGREDIENT

    Active Ingredient:

    Menthol 5%

  • PURPOSE

    Topical Analgesic

  • WARNINGS

    Warnings

    For external use only

  • WHEN USING

    When using this product

    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

    Keep out of reach of children

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

  • 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: consult your physical or occupational therapist.

  • 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: consult your physical or occupational therapist.
  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Butyrospermum Parkii (Shea) Butter, Cannabis Sativa (Hemp) Seed Oil and Hemp Oil and Hemp Derived Cannabidiol (CBD) Extract, Capsicum Frutescens Fruit Extract, Cetearyl Alcohol, Cetearyl Glucoside, Citrus Paradisi (Grapefruit) Extract, Cocos Nucifera (Coconut) Oil, Deionized Water, Emulsifying Wax, Hamamelis Virginiana (Witch Hazel), Magnesium Chloride, Mangifera Indica (Mango) Seed Butter, Mentha Piperita (Peppermint) Leaf Oil, Olea Europaea (Olive) Oil, Olus Oil (Vegetable), Phenoxyethanol, Xanthan Gum

  • QUESTIONS

    Manufactured for:

    X12LLC West Chester, PA 19380

    www.Magx12.com

  • INDICATIONS & USAGE

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

  • MAGNIFICENT_warming_Layered Label_FINALCorrected (2).jpg Magnificent_Round_Warming_CBD (2).jpg Magnificent-WARMING CBD_ART_Box_112718 (2).jpg

    Magnificent Round top labelMagnificent_Round_Warming_CBD (2).jpg

    Magnificent Warming BoxMAGNIFICENT WARMING LABEL

    MAGNIFICENT_warming_Layered Label_FINALCorrected (2).jpg

  • INGREDIENTS AND APPEARANCE
    MAGNIFICENT MENTHOL WARMING CREAM 
    menthol cream cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76348-422
    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)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    CANNABIDIOL (UNII: 19GBJ60SN5)  
    CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
    CORN OIL (UNII: 8470G57WFM)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    CAPSICUM (UNII: 00UK7646FG)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    WITCH HAZEL (UNII: 101I4J0U34)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    LAURETH-7 (UNII: Z95S6G8201)  
    GRAPEFRUIT OIL (UNII: YR377U58W9)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76348-422-021 in 1 BOX02/18/2019
    1NDC:76348-422-01112 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 finalpart34802/18/2019
    Labeler - RENU LABORATORIES, INC. (945739449)
    Establishment
    NameAddressID/FEIBusiness Operations
    Renu Laboratories, Inc.945739449manufacture(76348-422)

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