Active Ingredients
Histamine Dihydrochloride 0.05%
Australian Dream Back Pain Cream
FDA Label NDC 61577-8121
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sombra Cosmetics Inc. for the product Australian Dream Back Pain (NDC 61577-8121). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, keep out of reach of children, purpose, uses, warnings, directions, inactive ingredients, questions or comments?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away
Purpose
PURPOSE
Topical Analgesic
Uses
For temporary relief of minor aches and pains of muscles and joints associated with simple backache
Warnings
For external use only. Do not use on wounds or damaged skin or if you are allergic to ingredients in this 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 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.
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
Inactive Ingredients
Aloe Barbadensis Leaf (Aloe Vera Gel), Aqua (Purified Water), Ascorbic Acid (Vitamin C), Arnica Montana Flower Extract, Boswellia Serrata Extract, Bromelain, Butylene Glycol, Chamomilla Recutita (Chamomile) Extract, Emu Oil, Ethylhexylglycerin, Ethylhexyl Stearate, Ganoderma Lucidum (Reishi Mushroom) Extract, Glycyrrhiza Glabra (Licorice) Extract, Helianthus Annuus (Sunflower) Seed Oil, C13-14 Isoparaffin, Laureth-7, Magnesium Sulfate, Methylsulfonylmethane (MSM), Niacin, Phenoxyethanol, Polyacrylamide, Potassium Sorbate, Sodium Polyacrylate, Tetrasodium EDTA, Tochopheryl Acetate (Vitamin E), Trideceth-6, Turmeric Extract, Zingiber Officinalis (Ginger) Extract
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