Label: AUSTRALIAN DREAM PAIN RELIEVING ARTHRITIS - histamine dihydrochloride cream

  • NDC Code(s): 76017-100-02, 76017-100-04, 76017-100-09
  • Packager: Nature's Health Connection
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 02/11

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • ACTIVE INGREDIENT

    Active Ingredient

    Histamine dihydrochloride ...... 0.025%

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  • PURPOSE

    Purpose

    External Analgesic

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  • INDICATIONS & USAGE

    Uses

    • For the temporary relief of minor aches and pains of muscles and joints associated with arthritis.
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  • WARNINGS

    Warnings

    • For external use only.
    • Do not use on wounds or damaged skin or if you are allergic to ingredients in the product.
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  • WHEN USING

    When using this product

    • avoid contact with eyes. If product gets into eyes, rinse thoroughly with water.
    • do not bandage tightly.
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  • STOP USE

    Stop use and ask a doctor if

    • rash appears.
    • condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and occur again within a few days.
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  • PREGNANCY OR BREAST FEEDING

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

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

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

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  • DOSAGE & ADMINISTRATION

    Directions

    • For Use by Adults Only.
    • Apply to affected area no more than 3 to 4 times daily.
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  • SPL UNCLASSIFIED SECTION

    Other information

    • Store between 40 degrees F and 86 degrees F ( 4  degrees C and 30 degrees C).
    • Tamper Evident Feature: do not use if outer shrink wrap on jar is torn, broken or missing.
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  • INACTIVE INGREDIENT

    Inactive Ingredients Acrylamide/Sodium Acrylate Copolymer and Paraffinum Liquidum and Trideceth-6, Cosmoperine, Cyclodextrin, D-Glucosamine HCl, Dl Water, Emu Oil, Glycerin,  MSM, Phenoxyethanol, Caprylyl Glycol, Potassium Sorbate, Hexylene Glycol, Pregnenolone, Sodium Sulfite, Sodium Chondroitin Sulfate, Sorbitan Laurate and Polyglyceryl-4 Laurate and Dilauryl Citrate, Tetrasodium EDTA, Titanium Dioxide, Vitamin E.

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  • QUESTIONS


    Questions or Comments? Call 1.888.600.4645

    Distributed by: Nature's Health Connection, Inc. Campton, KY 41301
    www.AustralianDream.com
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  • PRINCIPAL DISPLAY PANEL

    Australian Dream

    Pain Relieving Arthritis Cream

    Net Wt. 4 oz (119g)

    Australian Dream 4oz



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  • INGREDIENTS AND APPEARANCE
    AUSTRALIAN DREAM PAIN RELIEVING ARTHRITIS 
    histamine dihydrochloride cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:76017-100
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3) HISTAMINE DIHYDROCHLORIDE 0.025 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    ACRYLAMIDE (UNII: 20R035KLCI)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    TRIDECETH-6 (UNII: 3T5PCR2H0C)  
    GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY)  
    WATER (UNII: 059QF0KO0R)  
    EMU OIL (UNII: 344821WD61)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    PREGNENOLONE (UNII: 73R90F7MQ8)  
    SODIUM SULFITE (UNII: VTK01UQK3G)  
    SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:76017-100-09 266 g in 1 JAR
    2 NDC:76017-100-04 119 g in 1 JAR
    3 NDC:76017-100-02 59 g in 1 JAR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 02/09/2011
    Labeler - Nature's Health Connection (079549213)
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