RAGING KAKAPO PAIN RELIEVE (CAPSAISIN AND HISTAMINE DIHYDROCHLORIDE) CREAM [EFFIHEALTH LLC]

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  • RAGING KAKAPO PAIN RELIEVE (CAPSAISIN AND HISTAMINE DIHYDROCHLORIDE) CREAM [EFFIHEALTH LLC]

RAGING KAKAPO PAIN RELIEVE (CAPSAISIN AND HISTAMINE DIHYDROCHLORIDE) CREAM [EFFIHEALTH LLC]
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NDC 70984-001-01
Set ID df302168-163d-44c6-b0d7-216c1f727dbd
Category HUMAN OTC DRUG LABEL
Packager EffiHealth LLC
Generic Name
Product Class
Product Number
Application Number PART348
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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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