Label: RAGING KAKAPO PAIN RELIEVE- capsaisin and histamine dihydrochloride 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 October 30, 2017

If you are a consumer or patient please visit this version.

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Capsaicin 0.025%Topical Analgesic
    Histamine Dihydrochloride 0.075%Topical Analgesic
  • Uses

    for the temporary relief of minor aches and pains of muscles and joints associated with

    • arthritis
    • simple backache
    • strains
    • bruises and sprains.
  • Warnings

    For external use only

    When using this product

    • use only as directed
    • do not bandage tightly
    • do not use with a heating pad
    • avoid contact with eyes and mucous membranes
    • do not apply to wounds, damaged, broken or irritated skin
    • a slight burning sensation may occur upon application
    • if severe burning occurs, discontinue use
    • do not expose the treated area to heat or direct sunlight
    • do not use if allergic to capsicum or chili peppers

    Stop use and ask a doctor if

    • condition worsens
    • rash appears
    • symptoms persist for more than 7 days or clear up and occur again within a few days
    • irritation develops

    If pregnant or breast feeding, ask a health professional before use.

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

  • Directions

    Adults and children over 18 years

    • apply generously to affected area not more than 3-4 times daily
    • massage into painful area until thoroughly absorbed
    • wash hands with soap and water after use

    Children 18 years or younger

    Ask a doctor

  • Other information

    Store between 40°F and 86°F (4°C and 30°C)

    • do not use if protective seal on jar is torn, broken or missing upon first use.
  • Inactive ingredients

    Deionized Water, Aloe Barbadensis Leaf Extract, Capric/Caprylic Triglyceride, Emu Oil, Stearic Acid, Cetyl Alcohol, Stearyl Alcohol, Eucalyptus Oil, Methylsulfonylmethane (MSM), Niacinamide, Boswellia, Steareth-21, Phenoxyethanol, Arnica Montana Extract, Sodium Hyaluronate, Green Mussel Extract, Glucosamine Sulfate, Tocopheryl Acetate, Pyridoxine Hydrochloride (Vitamin B6), Steareth-2, Sodium Hydroxide, Disodium EDTA, Caprylyl Glycol, Methylisothiazolinone

  • Questions or Comments?

    1-888-435-3108

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    EffiHealth Consumer Products
    259 Main Street, 2nd Floor Stamford, CT 06901

  • PRINCIPAL DISPLAY PANEL - 113.4 g Jar Carton

    NEW!

    Raging Kakapo™

    PAIN RELIEF CREAM

    Active Ingredients
    Histamine Dihydrochloride & Capsaicin

    Topical Analgesic
    NET WT. 4 OZ. (113.4g)

    Principal Display Panel - 113.4 g Jar Carton
  • INGREDIENTS AND APPEARANCE
    RAGING KAKAPO PAIN RELIEVE 
    capsaisin and histamine dihydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70984-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.25 mg  in 1 g
    histamine dihydrochloride (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3) histamine dihydrochloride0.75 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    Emu Oil (UNII: 344821WD61)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    Stearyl Alcohol (UNII: 2KR89I4H1Y)  
    Eucalyptus Oil (UNII: 2R04ONI662)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    Niacinamide (UNII: 25X51I8RD4)  
    INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
    Steareth-21 (UNII: 53J3F32P58)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    ARNICA MONTANA (UNII: O80TY208ZW)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    Glucosamine Sulfate (UNII: 1FW7WLR731)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Pyridoxine Hydrochloride (UNII: 68Y4CF58BV)  
    Steareth-2 (UNII: V56DFE46J5)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    Methylisothiazolinone (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70984-001-011 in 1 CARTON10/25/2017
    1113.4 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34810/25/2017
    Labeler - EffiHealth LLC (080382011)
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