Label: AUSTRALIAN DREAM BACK PAIN- histamine dihydrochloride cream

  • NDC Code(s): 76017-200-02, 76017-200-04, 76017-200-09
  • 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 17, 2017

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

  • Active ingredient

    Histamine Dihydrochloride 0.050%

    Close
  • Purpose

    Topical Analgesic

    Close
  • Uses

    • For the temporary relief of minor aches and pains of muscles
      and joints associated with simple backache.
    Close
  • Warnings

    • For external use only.

    Do not use

    on wounds or damaged skin or if you are allergic to ingredients in the product.

    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.

    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.

    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.

    Close
  • 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.
    Close
  • Other information

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

    Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Ascorbic Acid (Vitamin C), Arnica Montana Flower Extract, Boswellia Serrata Extract, Bromelain, Butylene Glycol, C13-14 Isoparaffin, Chamomilla Recutita (Chamomile) Extract, Deionized Water, Emu Oil, Ethylhexylglycerin, Ethylhexyl Stearate, Ganoderma Lucidum (Reishi Mushroom) Extract, Glycyrrhiza Glabra (Licorice) Extract, Helianthus Annuus (Sunflower) Oil, Laureth-7, Magnesium Sulfate, Methylsulfonylmethane (MSM), Niacin, Phenoxyethanol, Polyacrylamide, Potassium Sorbate, Sodium Polyacrylate, Tetrasodium EDTA, Tocopheryl Acetate (Vitamin E), Trideceth-6, Tumeric Extract, Zingiber Officinalis (Ginger) Extract

    Close
  • Questions or Comments?

    Call 1.888.600.4642

    Close
  • Package Label
  • INGREDIENTS AND APPEARANCE
    AUSTRALIAN DREAM BACK PAIN 
    histamine dihydrochloride cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:76017-200
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3) HISTAMINE DIHYDROCHLORIDE 0.05 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
    BROMELAINS (UNII: U182GP2CF3)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ)  
    WATER (UNII: 059QF0KO0R)  
    EMU OIL (UNII: 344821WD61)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
    REISHI (UNII: TKD8LH0X2Z)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    LAURETH-7 (UNII: Z95S6G8201)  
    MAGNESIUM SULFATE (UNII: DE08037SAB)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    NIACIN (UNII: 2679MF687A)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TRIDECETH-6 (UNII: 3T5PCR2H0C)  
    TURMERIC (UNII: 856YO1Z64F)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:76017-200-04 119 g in 1 JAR; Type 0: Not a Combination Product 02/05/2017
    2 NDC:76017-200-02 59 g in 1 JAR; Type 0: Not a Combination Product 02/05/2017
    3 NDC:76017-200-09 266 g in 1 JAR; Type 0: Not a Combination Product 02/05/2017
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 07/10/2014
    Labeler - Nature's Health Connection (079549213)
    Close