Australian Dream Back Pain

Australian Dream Back Pain is an FDA-registered drug product whose active ingredient is HISTAMINE DIHYDROCHLORIDE. It is labelled by Sombra Cosmetics Inc. taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 61577-8121, application M017, label effective 20260521. It is one of 6 FDA drug label records sharing the active ingredient HISTAMINE DIHYDROCHLORIDE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing HISTAMINE DIHYDROCHLORIDE are most often described in connection with: indications usage, temporary relief, minor aches, pains muscles, joints associated, arthritis simple, backache strains, product avoid. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Indications & Usage Section For temporary relief of minor aches and pains of muscles and joints associated with arthritis, simple backache, strains and bruises. 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.

Dosage and Administration Apply a thin layer to pain site and massage until thoroughly absorbed into skin. Apply no more than 3 to 4 times daily.

Warnings Section 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.

FDA lists 6 drug label records with HISTAMINE DIHYDROCHLORIDE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

What is Australian Dream Back Pain used for?
Indications & Usage Section For temporary relief of minor aches and pains of muscles and joints associated with arthritis, simple backache, strains and bruises. 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.

Who makes Australian Dream Back Pain?
Sombra Cosmetics Inc. is the labeler of record for Australian Dream Back Pain. 6 FDA label records share the active ingredient HISTAMINE DIHYDROCHLORIDE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Australian Dream Back Pain come in?
administered by topical. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Australian Dream Back Pain prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing HISTAMINE DIHYDROCHLORIDE?
Yes. 6 FDA drug label records list HISTAMINE DIHYDROCHLORIDE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Australian Dream Back Pain been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.