Label: ELEVATE CBD HEATING THERAPY- menthol cream

  • NDC Code(s): 76348-455-01
  • 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

If you are a consumer or patient please visit this version.

View All Sections
  • ACTIVE INGREDIENT

    Menthol 5%

  • 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

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

    Keep out of reach of children.

    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.
  • PURPOSE

    Purpose

    Topical Analgesic

  • QUESTIONS

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

  • INDICATIONS & USAGE

    Uses: For external use on muscles and joints where you feel soreness.

  • DOSAGE & ADMINISTRATION

    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 doctor
  • STORAGE AND HANDLING

    Other information

    Keep out of direct sunlight.

  • INACTIVE INGREDIENT

    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, Emusifying 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

  • DESCRIPTION

    Elevate Topical Cream helps unlock the body's ECS receptors to assist in one's well being and is Doctor formulated with menthol and magnesium to aid in relief. Elevate Topical Cream is pharmaceutically produced and lab tested for purity, quality and safety.

  • PRINCIPAL DISPLAY PANEL

    4.0 oz. heating ElevateELEVATE HEATING THERAPY TOPICAL CREAM LABEL

  • INGREDIENTS AND APPEARANCE
    ELEVATE CBD HEATING THERAPY 
    menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76348-455
    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
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    WATER (UNII: 059QF0KO0R)  
    POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
    MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
    CANNABIDIOL (UNII: 19GBJ60SN5)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    LAURETH-7 (UNII: Z95S6G8201)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    WITCH HAZEL (UNII: 101I4J0U34)  
    CORN OIL (UNII: 8470G57WFM)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    TABASCO PEPPER (UNII: J1M3NA843L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76348-455-01112 g in 1 JAR; 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(76348-455)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!