Label: MY HEMP MD CBD MUSCLE AND DEEP TISSUE CREAM- menthol and methyl salicylate cream

  • 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 March 26, 2020

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  • ACTIVE INGREDIENT

    Active Ingredients....................Purpose

    Menthol 5%................................External Analgesic

    Methyl Salicylate 10%..................External Analgesic

  • PURPOSE

    External Analgesic

  • INDICATIONS & USAGE

    Uses: Temporarily helps relieve minor aches and pains of muscle and joints associated with simple backaches, arthritis, sprains, bruises and strains.

  • Warnings

    For external use only

    When using tthis product:

    • Do not get into eyes.

    Stop use and ask a doctor if:

    • Condition worsens
    • Symptoms last 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.

    Directions:

    Apply twice daily for best results.

  • Other information:

    • External use only. If irratation should occur discontinue use.
    • When using this product you may notice a slight tingling sensation; this is normal and will subside.
    • Do not use if quality seal is broken or missing.
  • Inactive ingredients:

    Alpha-Tocopherol Acetate (Vitamin E), Aminomethylpropanol, Arnica Montana Flower, Camphor Oil, Cannabidiol, Carbomer Homopolymere Type C, Cetostearyl Alcohol, Clove Leaf Oil, Dimethyl Sulfone, Dimethyl Sulfoxide, Ethylhexylglycerin, Glyceryl Stearate/PEG-100 Stearate, Hemp, Magnesium Hydroxide, Phenoxyethanol, Polysorbate 80, Water

  • QUESTIONS

    Questions?

    Call 770-303-0797

    www.myhempmd.com

  • SPL UNCLASSIFIED SECTION

    Distributed by: My Hemp MD

    Marietta, GA 30067

  • PRINCIPAL DISPLAY PANEL

    bottlebottle

  • PRINCIPAL DISPLAY PANEL

    cartoncarton

  • INGREDIENTS AND APPEARANCE
    MY HEMP MD CBD MUSCLE AND DEEP TISSUE CREAM 
    menthol and methyl salicylate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52261-5202
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.10 kg  in 1 kg
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE0.15 kg  in 1 kg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    DIMETHYL SULFOXIDE (UNII: YOW8V9698H)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    HEMP (UNII: TD1MUT01Q7)  
    CANNABIDIOL (UNII: 19GBJ60SN5)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947)  
    CAMPHOR OIL (UNII: 75IZZ8Y727)  
    CLOVE LEAF OIL (UNII: VCA5491KVF)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52261-5202-11 in 1 CARTON11/01/2019
    1NDC:52261-5202-00.075 kg in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34811/01/2019
    Labeler - Cosco International, Inc. (016433141)
    Registrant - Cosco International, Inc. (016433141)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosco International, Inc.016433141manufacture(52261-5202) , label(52261-5202) , pack(52261-5202)
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