Label: MD SCIENCE CANNABIDIOL- lidocaine and histamine dihydrochloride cream

  • Category: HUMAN OTC DRUG LABEL

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 February 10, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose  
    Lidocaine 4%Analgesic
    Histamine Dihydrochloride 0.08%Counterirritant
  • Use

    Helps in temporary pain relief

  • Warnings

    If this product, used as directed, does not provide relief, discontinue use and consult a doctor.

    • For topical use only.
    • Do not bandage tightly

    • Do not use if you are allergic to Lidocaine or topical anesthetics.

    • Discontinue use if you develop a rash or irritation, such as burning or itching.

    • If symptoms persist, consult a doctor.

    • Do not use on broken, irritated or sensitive skin.

    • Avoid contact with eyes.
    • For external use only.

    • Keep out of reach of children.
    • If swallowed, get medical help or contact a Poison Control Center.
  • Directions

    Apply desired amount directly to the area to be affected.

  • Other Information

    STORE AT 20-25° C (68-77° F)

  • Inactive Ingredients

    Aloe Barbadensis (Aloe)Leaf Juice, Caprylhydroxamic Acid, Caprylyl Glycol, Carbomer, CBD (Cannabidiol), Cetyl Esters, Cocos Nucifera (Coconut) Oil, Emu Oil, Glycerin, Glyceryl Stearate, Isopropyl Palmitate, Methylsulfonylmethane (MSM), Sodium Hydroxide, Sorbitol, Steareth-21, Stearyl Alcohol, Water.

  • SPL UNCLASSIFIED SECTION

    Distributed By:
    MD Natural Health

    2590 N. Powerline Rd
    Pompano Beach
    Florida 33069

  • PRINCIPAL DISPLAY PANEL - 88 ML Bottle Box

    MDSCIENCE™
    CANNABIDIOL
    THE SCIENCE OF HEALTHY

    CBD

    500MG TOTAL CBD
    MUSCLE AND JOINT
    PAIN RELIEF
    CREAM

    3FL OZ (88ML)

    PRINCIPAL DISPLAY PANEL - 88 ML Bottle Box
  • INGREDIENTS AND APPEARANCE
    MD SCIENCE CANNABIDIOL 
    lidocaine and histamine dihydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73615-103
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Lidocaine (UNII: 98PI200987) (Lidocaine - UNII:98PI200987) Lidocaine37.8 mg  in 1 mL
    Histamine Dihydrochloride (UNII: 3POA0Q644U) (Histamine - UNII:820484N8I3) Histamine Dihydrochloride0.041 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    Caprylhydroxamic Acid (UNII: UPY805K99W)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    Carbomer Homopolymer Type C (Allyl Pentaerythritol Crosslinked) (UNII: 4Q93RCW27E)  
    Cannabidiol (UNII: 19GBJ60SN5)  
    Cetyl Esters Wax (UNII: D072FFP9GU)  
    Coconut Oil (UNII: Q9L0O73W7L)  
    Emu Oil (UNII: 344821WD61)  
    Glycerin (UNII: PDC6A3C0OX)  
    Glyceryl Monostearate (UNII: 230OU9XXE4)  
    Isopropyl Palmitate (UNII: 8CRQ2TH63M)  
    Dimethyl Sulfone (UNII: 9H4PO4Z4FT)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Sorbitol (UNII: 506T60A25R)  
    Steareth-21 (UNII: 53J3F32P58)  
    Stearyl Alcohol (UNII: 2KR89I4H1Y)  
    Product Characteristics
    ColorPINKScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73615-103-031 in 1 BOX02/15/2020
    188 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34802/15/2020
    Labeler - MD NATURAL HEALTH LLC (080706676)
    Establishment
    NameAddressID/FEIBusiness Operations
    PACKAGE SOLUTIONS LLC054705875MANUFACTURE(73615-103)