Label: HAPPY ELF CBD PAIN RELIEF CREAM- menthol, 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 19, 2020

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  • DRUG FACTS

    Menthol - 5% (External Analgesic)
    Methyl Salicylate (NSAID) – 7.5% (External Analgesic)

    Uses:

    For temporary relief of minor aches and pains of muscles and joints associated with backache, muscle ache, strains, sprains, bruises, cramps, arthritis, and inflammation

  • WARNINGS:

    External Use Only!

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

    Do not use:
    • on wounds or damaged skin
    • with a heating pad
    • on a child under 12 years of age with arthritis-like conditions

    Ask a doctor before use if you have redness over the affected area.

    If pregnant or breast-feeding, or if you have sensitive skin, ask your doctor before use

    Avoid contact with eyes. If contact occurs, flush thoroughly with water.

    When using this product:
    • avoid contact with eyes or mucous membranes
    • do not bandage tightly

    Stop use and ask a doctor if: condition worsens or symptoms persist for more than 7 days, symptoms clear up and occur again within a few days, excessive skin irritation occurs

  • Directions: 

    Use only as directed. Apply generously and massage to affected area as needed. Do not use more than 3 to 4 times per day.
    Children under 12 years of age: ask a doctor before use.

  • Inactive Ingredients:

    Alpha-Tocopherol Acetate (Vitamin E), Aminomethylpropanol, Arnica Montana Flower, Cannabis Sativa Whole, Carbomer, Cetostearyl Alcohol, Dimethyl Sulfone, Dimethyl Sulfoxide, Ethylhexyl Palmitate, Ethylhexylglycerin, Glucosamine, Glyceryl Monostearate, Magnesium Hydroxide, Phenoxyethanol, Polysorbate 80, Water

  • Other Information:

    Store at room temperature 68°F to 77°F (20° to 25°C)
    Do not expose to excessive heat

  • Allergy Alert:

    Do not use if you are allergic to salicylates (including aspirin) without consulting a physician.

  • For Questions

    Call +1 (239) 236-8158
    Happy Elf CBD Corporation
    2250 NW 102 PL
    Miami, FL 33172
    Website: www.happyelf.com.com

  • PRINCIPAL DISPLAY PANEL

    CBD Pain Cream Tube Label

  • PRINCIPAL DISPLAY PANEL

    CBD Pain Cream Box Label

  • INGREDIENTS AND APPEARANCE
    HAPPY ELF CBD PAIN RELIEF CREAM 
    menthol, methyl salicylate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73658-3400
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.05 kg  in 1 kg
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE0.075 kg  in 1 kg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    DIMETHYL SULFOXIDE (UNII: YOW8V9698H)  
    GLUCOSAMINE (UNII: N08U5BOQ1K)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    CANNABIS SATIVA WHOLE (UNII: B5ONF538PB)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73658-3400-11 in 1 PACKAGE03/20/2020
    1NDC:73658-3400-00.114 kg in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/19/2020
    Labeler - Happy Elf CBD Corporation (117409880)
    Registrant - Happy Elf CBD Corporation (117409880)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosco International, Inc016433141manufacture(73658-3400) , relabel(73658-3400) , pack(73658-3400)
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