Label: ELEVATE HEATING THERAPY TWIST UP- menthol cream cream

  • NDC Code(s): 76348-454-01
  • 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 January 13, 2022

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  • ACTIVE INGREDIENT

    Active Ingredient

    Menthol 5%

  • PURPOSE

    Purpose

    Topical Analgesic

  • INDICATIONS & USAGE

    Uses

    • For external use on muscles and joints where you feel soreness
  • WARNINGS

    Warnings

    • For external use only
    • 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 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

    • Massage desired amount into affected skin area no more than 10 times daily or as directed by your doctor.
    • children under 12 years of age consult your physician.
  • Other information

    • Keep out of direct sunlight.
  • INACTIVE INGREDIENT

    Inactive Ingredients Butyrospermum Parkii (Shea) Butter, C13-14 Isoparaffin, Cannabis Sativa (Hempseed) Oil and Hemp Derived Cannabidiol (CBD) Extract, Capsicum Frutescens (Pepper) Fruit Extract, Cetearyl Alcohol, Cetearyl Glucoside, Cocos Nucifera (Coconut) Oil, Deionized Water, Emulsifying Wax, Glyceryl Stearate, Grapefruit Oil, Hamamelis Virginiana (Witch Hazel), Laureth-7, Magnesium Chloride, Magnesium Sulfate, Mangifera Indica (Mango) Seed Butter, Mentha Piperita (Peppermint) Oil, Mint Oil, Olea Europaea (Olive) Oil, Olus (Vegetable) Oil, PEG-100, Phenoxyethanol, Polyacrylamide, Stearic Acid

  • QUESTIONS

    Questions? Call 215.660.9123 or email us at info@elevatecbd.com

  • DOSAGE & ADMINISTRATION

    Massage desired amount into affected skin area no more than 10 times daily or as directed by your doctor

  • PRINCIPAL DISPLAY PANEL

    2oz-stick

    Elevate 2oz Cream Stick

  • INGREDIENTS AND APPEARANCE
    ELEVATE HEATING THERAPY TWIST UP 
    menthol cream cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76348-454
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.8 g  in 56 g
    Inactive Ingredients
    Ingredient NameStrength
    CANNABIDIOL (UNII: 19GBJ60SN5)  
    CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    LAURETH-7 (UNII: Z95S6G8201)  
    WITCH HAZEL (UNII: 101I4J0U34)  
    POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
    MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    CORN OIL (UNII: 8470G57WFM)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    WATER (UNII: 059QF0KO0R)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    TABASCO PEPPER (UNII: J1M3NA843L)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76348-454-0156 g in 1 APPLICATOR; Type 0: Not a Combination Product10/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34810/01/2019
    Labeler - RENU LABORATORIES, INC. (945739449)
    Establishment
    NameAddressID/FEIBusiness Operations
    Renu Laboratories, Inc.945739449manufacture(76348-454)
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