Australian Dream Back Pain Cream

Manufacturer
Sombra Cosmetics Inc.
Effective date
2026-05-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:58:36

Label at a glance#

ProductAustralian Dream Back Pain
Active ingredientHISTAMINE DIHYDROCHLORIDE
Label structure13 sections

Indications and uses

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

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

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Histamine Dihydrochloride .025%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children and pets. If swallowed, get medical help or contact a Poison Control Center right away

Uses

OTC - WHEN USING 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.

Warnings

OTC - STOP USE 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.

Directions

OTC - WHEN USING SECTION

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

INACTIVE INGREDIENT SECTION

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

Questions or Comments

OTC - QUESTIONS SECTION

Call 1-888-600-4642

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

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.

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.

Indications and Usage Section

RECENT MAJOR CHANGES SECTION

January 2024:

For temporary relief of minor aches and pains of muscles and joints associated with simple backache

March 2026:

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.

AD 2 oz Back Pain Cream Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AD 2 oz Back Pain Cream BoxAD 2 oz Back Pain Cream Box

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1542820histamine dihydrochloride 0.05 % Topical CreamPSN1
1542820histamine dihydrochloride 0.5 MG/ML Topical CreamSCD1
1542820histamine dihydrochloride 0.05 % Topical CreamSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2dae634-14ed-febf-08ee-93196433b5b7Product name920190614
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
0a5e5249-329b-0cff-e714-77159f193a87Product name120140508
6b7a6f32-42a6-994d-5ab6-d180e92ee9d8Product name120140508
d394f843-7479-dc48-dbd3-232266c5548cProduct name120140508
dc9a5fb6-14e2-1cc8-a567-a781fd1f0212Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61577-8121-2Australian Dream Back Pain59 g in 1 JARCREAM591
61577-8121-3Australian Dream Back Pain1 in 1 CARTONCREAM11
61577-8121-4Australian Dream Back Pain119 g in 1 JARCREAM1191
61577-8121-5Australian Dream Back Pain1 in 1 CARTONCREAM11
61577-8121-8Australian Dream Back Pain1 in 1 CARTONCREAM11
61577-8121-9Australian Dream Back Pain266 g in 1 JARCREAM2661

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61577-812161577-8121-2, 61577-8121-3, 61577-8121-4, 61577-8121-5, 61577-8121-9, 61577-8121-8

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Australian Dream Back PainHISTAMINE DIHYDROCHLORIDESombra Cosmetics Inc.5256a63e-e6da-84c1-e063-6294a90a8dff2026-05-21WarningsExact identifier
ndc (package): 61577-8121-8
ndc (package): 61577-8121-4
ndc (package): 61577-8121-5
ndc (package): 61577-8121-9
ndc (package): 61577-8121-2
ndc (package): 61577-8121-3
ndc (product): 61577-8121
ndc11 (package): 61577812104
ndc11 (package): 61577812103
ndc11 (package): 61577812105
ndc11 (package): 61577812102
ndc11 (package): 61577812109
ndc11 (package): 61577812108
spl id: 5256a63e-e6db-84c1-e063-6294a90a8dff
spl set id: 5256a63e-e6da-84c1-e063-6294a90a8dff