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

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 February 8, 2017

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active Ingredient

    Histamine dihydrochloride ...... 0.025%

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  • Purpose

    External Analgesic

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  • Uses

    • For the temporary relief of minor aches and pains of muscles and joints associated with arthritis, simple backache, strains & bruises.
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  • 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 this product

    • avoid contact with eyes. If product gets into eyes, rinse thoroughly with water.
    • do not bandage tightly or use a heating pad.
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  • 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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  • If pregnant or breast feeding,

    ask a health professional before use.

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  • Keep out of reach of children.

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

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  • Directions

    • For Use by Adults and Children over 12 years.
    • Apply a thin layer to pain site and massage until thoroughly absorbed into skin. Apply no more than 3 to 4 times daily.
    • Children 12 years or younger consult a physician.
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  • Other information

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

    Deionized Water, Emu Oil, Butylene Glycol, Methylsulfonylmethane (MSM), Helianthus Annuus (Sunflower) Oil, Polyacrylamide, Sodium Polyacrylate, C13-14 Isoparafiin, Ethylhexyl Stearate, Glucosamine Sulfate, Chondroitin Sulfate, Tocopheryl Acetate (Vitamin-E), Trideceth-6, Laureth-7, Tetrasodium EDTA, Potassium Sorbate, Methylisothiazolinone

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  • Questions or Comments? Call 1.888.600.4642

    Distributed by: Nature's Health Connection ® Inc.
    PO Box 609, 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
    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
    TRIDECETH-6 (UNII: 3T5PCR2H0C)  
    WATER (UNII: 059QF0KO0R)  
    EMU OIL (UNII: 344821WD61)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    DIMETHYL SULFOXIDE (UNII: YOW8V9698H)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
    GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
    LAURETH-7 (UNII: Z95S6G8201)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:76017-100-09 266 g in 1 JAR; Type 0: Not a Combination Product 02/07/2017
    2 NDC:76017-100-04 119 g in 1 JAR; Type 0: Not a Combination Product 02/07/2017
    3 NDC:76017-100-02 59 g in 1 JAR; Type 0: Not a Combination Product 02/07/2017
    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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