Label: CANNASERENE HOT AND COLD CBD CREAM- hot and cold cream cream

  • NDC Code(s): 74787-1801-0, 74787-1801-2, 74787-1801-3
  • Packager: BioSerene 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 May 10, 2023

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  • Active Ingredients

    Active Ingredients

  • Uses

    Temporary relief from minor aches and pains of sore muscles and joints associated with: arthritis, backaches, strains, bruises, sprains, and pulled muscles.

  • Purpose

    Topical Analgesic

  • Directions

    • Adults and children 12 years of age and older: Massage over affected areas no more than 3 to 4 times daily. Wash hands after use.
    • Children under 12 years of age: consult a doctor.
  • Warnings

    FOR EXTERNAL USE ONLY.

    Flammable. Keep away from fire or flame.

    Allergy Alert. If prone to allergic reaction from aspirin or salicylates, consult doctor before use.

    Do Not Use

    Do not use on wounds or damaged skin or with a heating pad.

    When Using This Product

    • Use only as directed
    • Avoid contact with eyes or mucous membranes
    • Do not bandage tightly

    Stop Use and Ask a Doctor

    • If condition worsens
    • Symptoms persist more than 7 days or clear up and occur again within a few days
    • Excessive skin irritation develops.

    Keep Out of Reach of Children

    If swallowed, get medical help or contact a Poison Control Center immediately.

  • Storage and Handling

    Store at controlled room temperature 20°-25°C (68°-77°F). Keep away from direct sunlight.

  • Inactive Ingredients

    Purified Water, Menthol, Gaultheria Procumbens (Wintergreen) Leaf Oil, Fractionated Coconut Oil, Polysorbate 80, Sorbitan Stearate, Cetearyl Alcohol, Isopropyl Myristate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Cannabidiol, Dimethyl Isosorbide, Oenothera Biennis (EveningPrimrose) Oil, Tocopherol Acetate (VitaminE), Propylene Glycol, Diazolidinyl Urea, Iodopropynyl Butylcarbamate

  • Labeling

    CannaSerene Hot & Cold CBD Cream - For Tired Joints & Muscles

    CBD 1200MG (for 100mL)

    CBD Isolate 12mg/ml

    • Made in USA
    • Formulated By a Pharmacist
    • cGMP Certified

    Manufactured By: BioSerene, Inc.

    4398 SW Port Way, Palm City, FL 34990 USA

    Product Label

  • INGREDIENTS AND APPEARANCE
    CANNASERENE HOT AND COLD CBD CREAM 
    hot and cold cream cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74787-1801
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE4 g  in 100 mL
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
    CANNABIDIOL (UNII: 19GBJ60SN5)  
    DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)  
    EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74787-1801-3100 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/14/202201/20/2025
    2NDC:74787-1801-250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/14/202201/20/2025
    3NDC:74787-1801-010 mL in 1 TUBE; Type 0: Not a Combination Product06/14/202201/20/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/14/202201/20/2025
    Labeler - BioSerene Inc. (117473724)
    Establishment
    NameAddressID/FEIBusiness Operations
    BioSerene Inc.117473724manufacture(74787-1801)
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