Australian Dream Arthritis 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 01:58:27

Label at a glance#

ProductArthritis Pain Relief Cream
Active ingredientHISTAMINE DIHYDROCHLORIDE
Label structure13 sections

Indications and uses

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

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

External Analgesic

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Uses

OTC - WHEN USING SECTION

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

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 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 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.

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

Aqua (Purified Water), Butylene Glycol, Emu Oil, Ethylhexylglycerin, Ethylhexyl Stearate, Helianthus
Annuus (Sunflower) Seed Oil, C13-14 Isoparaffin, Laureth-7, Methylsulfonylmethane (MSM),
Polyacrylamide, Potassium Sorbate, Sodium Polyacrylate, Tetrasodium EDTA, Tochopheryl Acetate
(Vitamin E), Trideceth-6, Chondroitin Sulfate, Glucosamine Sulfate

Questions or Comments

OTC - QUESTIONS SECTION

Call 1-888-600-4642

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

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 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 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.

Indications and Usage Section

INDICATIONS & USAGE 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.

Indications and Usage

RECENT MAJOR CHANGES SECTION

12/2019 Submission Indications and Usage Section:

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

3/2026 Submission Indications and Usage 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.

AD Arthritis 9oz Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AD Arthritis 9oz CartonAD Arthritis 9oz Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1091387histamine dihydrochloride 0.025 % Topical CreamPSN1
1091387histamine dihydrochloride 0.25 MG/ML Topical CreamSCD1
1091387histamine dihydrochloride 0.025 % Topical CreamSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61577-8120-1Arthritis Pain Relief Cream1 in 1 CARTONCREAM11
61577-8120-2Arthritis Pain Relief Cream59 g in 1 JARCREAM591
61577-8120-4Arthritis Pain Relief Cream119 g in 1 JARCREAM1191
61577-8120-5Arthritis Pain Relief Cream1 in 1 CARTONCREAM11
61577-8120-8Arthritis Pain Relief Cream1 in 1 CARTONCREAM11
61577-8120-9Arthritis Pain Relief Cream266 g in 1 JARCREAM2661

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61577-812061577-8120-4, 61577-8120-5, 61577-8120-9, 61577-8120-8, 61577-8120-2, 61577-8120-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 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
Arthritis Pain Relief CreamHISTAMINE DIHYDROCHLORIDESombra Cosmetics Inc.523333ee-eccd-bcf7-e063-6394a90aea602026-05-21WarningsExact identifier
ndc (package): 61577-8120-8
ndc (package): 61577-8120-5
ndc (package): 61577-8120-4
ndc (package): 61577-8120-2
ndc (package): 61577-8120-9
ndc (package): 61577-8120-1
ndc (product): 61577-8120
ndc11 (package): 61577812008
ndc11 (package): 61577812004
ndc11 (package): 61577812009
ndc11 (package): 61577812005
ndc11 (package): 61577812001
ndc11 (package): 61577812002
spl id: 523333ee-ecce-bcf7-e063-6394a90aea60
spl set id: 523333ee-eccd-bcf7-e063-6394a90aea60

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.