Label: LEAFPRO CBDMED OIL T-FS QD 20%- cannabidiol oil

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: CV
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated March 13, 2020

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  • Drug Facts

    Drug Facts

  • Active Ingredient

    Cannabidiol 20%

  • Purpose

    Anti-inflammatory, analgesic and sedative

  • Uses

    • pain relief
    • inflammation relief
    • soothing and relaxing effect
  • Warnings

    Allergy alert:

    do not use in case of hypersensitivity (allergy) to any of the ingredients.

    Ask a doctor before use if

    you have

    • hepatopathy
    • depression
    • neural disease

    Possible side effects are

    • sleepiness
    • increase in liver enzymes
    • feeling very tired and weak

    Stop use and ask a doctor if

    you experience any side effects not listed on this carton.

    Ask a doctor or pharmacist before use if

    you are taking sleeping pills, tranquilizers, sedatives or other medicines.

    When using this product

    • avoid alcoholic drinks
    • alcohol, sleeping pills, tranquilizers and sedatives may increase drowsiness and may impair mental and/or physical abilities
    • be careful when driving a motor vehicle or operating machinery

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

  • Directions

    • shake well before use
    • adults and children 12 years and over: take 1 – 3 drops under your tongue and hold it there for as long as possible before swallowing
    • repeat procedure if required
    • do not exceed the recommended daily dose of 400mg CBD (40 drops)
    • for full therapeutic effect use regularly for a period of at least 4-12 weeks
  • Other information

    • store at 15-25°C (59-77°F)
    • protect from excessive moisture
    • protect from direct sunlight
    • TAMPER EVIDENT: do not use if cap safety seal is broken
  • Inactive ingredients:

    Full spectrum hemp extract (THC-free), MCT coconut oil, silicon dioxide

  • Questions and comments:

    Phone: +1-212-5844230

    E-Mail: info@leafpharma-inc.com

  • Principal Display Panel - 10ml

    leaf Pro
    CBDmed Oil
    T-FS QD
    20%
    Cannabidiol
    Pain-relieving, anti-inflammatory, soothing and relaxing effect
    10ml / 0.34 fl oz

    Principal display panel_Carton 10ml

    Principal display panel_Label 10ml

  • INGREDIENTS AND APPEARANCE
    LEAFPRO CBDMED OIL T-FS QD 20% 
    cannabidiol oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73674-024
    Route of AdministrationORALDEA ScheduleCV    
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CANNABIDIOL (UNII: 19GBJ60SN5) (CANNABIDIOL - UNII:19GBJ60SN5) CANNABIDIOL20 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    HEMP (UNII: TD1MUT01Q7)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73674-024-011 in 1 CARTON04/01/2020
    110 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other04/01/2020
    Labeler - leafMed GmbH (342895093)
    Registrant - Leafpharma Inc. (117330180)
    Establishment
    NameAddressID/FEIBusiness Operations
    leafMed GmbH342895093manufacture(73674-024) , pack(73674-024) , label(73674-024)
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