Label: ELEVATE COOLING THERAPY TWIST UP- menthol cream

  • NDC Code(s): 76348-456-01
  • 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

    Menthol

  • 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.

  • PURPOSE

    Purpose

    Topical Analgesic

  • QUESTIONS

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

  • 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.
  • OTHER SAFETY INFORMATION

    Other information

    • Keep out of direct sunlight
  • STATEMENT OF IDENTITY

    elevate CBD COOLING THERAPY TWIST UP TOPICAL with Menthol

  • INDICATIONS & USAGE

    Uses

    • For external use on muscles and joints where you feel soreness
  • DOSAGE & ADMINISTRATION

    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.

  • WARNINGS

    Warnings

    • For external use only
    • When using this product do not bandage tightly
    • avoid contact with eyes
    • do not apply to to wounds or damaged skin
    • do not use with heating pads or other heating devices
  • INACTIVE INGREDIENT

    Inactive Ingredients

    Butyrospermum Parkii (Shea) Butter, C13-14 Isoparaffin, Cannabis Sativa (Hempseed) Oil and Hemp Derived Cannabidiol (CBD) 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

  • PRINCIPAL DISPLAY PANEL

    elevate Twist Up Topical label

    2oz stick label

  • INGREDIENTS AND APPEARANCE
    ELEVATE COOLING THERAPY TWIST UP 
    menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76348-456
    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
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    WITCH HAZEL (UNII: 101I4J0U34)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
    CANNABIDIOL (UNII: 19GBJ60SN5)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)  
    POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    WATER (UNII: 059QF0KO0R)  
    MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947)  
    CORN OIL (UNII: 8470G57WFM)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    LAURETH-7 (UNII: Z95S6G8201)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76348-456-0156 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(76348-456)
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