Australian Dream Power 4 Muscle and Joint Pain Relief Cream

Manufacturer
Sombra Cosmetics, Inc.
Effective date
2023-05-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:54:54

Label at a glance#

ProductAustralian Dream Power 4 Muscle and Joint Pain Relief Cream
Active ingredientMETHYL SALICYLATE, MENTHOL, CAMPHOR (SYNTHETIC), CAPSAICIN
Label structure9 sections

Indications and uses

For temporary relief of minor aches and pains of muscles and joints associated with arthritis, simple backache, strains, sprains, and bruises.

Dosage and administration

​For use by adults 18 years of age and older. ​Apply a thin layer to affected area not more than 3 to 4 times daily. Wash hands with soap or dishwashing liquid after application. If using on hands, allow 30 minutes for absorption before washing hands. Massage intopainful area until thoroughly absorbed into skin.  ​Children under 18 years consult a physician.  ​Store between 40F and 86F (4C and 30C), Tamper Evident...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Camphor 3%, Capsaicin 0.025%, Methyl Salicylate 10%, Menthol 3%

Keep out of reach of children and pets.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away

PURPOSE

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

For temporary relief of minor aches and pains of muscles and joints associated with arthritis, simple backache, strains, sprains, and bruises.

Warnings

WARNINGS SECTION

For external use only. Allery Alert: If prone to allergic reaction from asprin or salicylates, capsisum or chili peppers, or any ingredients in this product, consult a doctor before use. ​​Do not use ​on wounds or damaged, broken, or irritated skin, at the same time as other topical analgesics. ​When using this product​, use only as directed. ​Read and follow all directions and warning on this label. Aviod contact with eyes and mucous membranes. If contact is made, rinse thoroughly with water. Rare cases of serious burns have been reported with this type of product. Avoid applying into skin folds. Discontinue use at leat 1 hour before a bath, shower, swim, or sweating. Do not bandage tightly or apply local heat (such as heating pads) or a medicated patch to the area of use. A transient burning sensation may occur upon application but generlly disappears in several days. If severe burning sensation occurs, discontinue use immediately. Do notexpoes the area treated with product to heat or direct sunlight. ​Stop use and ask a doctor if, ​rash, redness or irritation appears, condition worsens, symtoms persist for more than 7 days or clear up and occur again within a few days. ​If pregnant or breast-feeding, ​ask a health care professional before use. 

Directions

DOSAGE & ADMINISTRATION SECTION

​For use by adults 18 years of age and older. ​Apply a thin layer to affected area not more than 3 to 4 times daily. Wash hands with soap or dishwashing liquid after application. If using on hands, allow 30 minutes for absorption before washing hands. Massage intopainful area until thoroughly absorbed into skin. ​Children under 18 years consult a physician. ​Store between 40F and 86F (4C and 30C), Tamper Evident Feature: do not use if outer shrink wrap on jar is torn, broken or missing.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis (Aloe Vera) Leaf Juice, Caprylyl Glycol, Carbomer, Cetearyl Alcohol, Emu Oil, Glycerin, Phenoxyethanol, Polysorbate 60, Purifed Water, Sodium Carbonate, Stearic Acid, Tocopheryl Acetate, Yucca Schidigera Root Extract.

Questions or Comments?

OTC - QUESTIONS SECTION

Call 1-888-600-4642

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61577-8220-42025-01-30C16284748780-12cef2736-6685-d83d-e063-dadaa90ab31fAustralian Dream Power 4 Muscle & Joint Pain Relief Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61577-8220-4Australian Dream Power 4 Muscle and Joint Pain Relief Cream119 g in 1 JARCREAM1191

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61577-8220AUSTRALIAN DREAM POWER 4 MUSCLE AND JOINT PAIN RELIEF CREAM (CAMPHOR, MENTHOL, CAPSACIN, METHYL SALICYLATE) CREAM [SOMBRA COSMETICS, INC.]11 package rows20230511_2c3e3a3c-d7f1-4893-9080-849fcf0f04e5.zip

Products#

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

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61577-822061577-8220-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 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.

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f6c7ee2a-de64-46a9-9d94-f62987675c282c3e3a3c-d7f1-4893-9080-849fcf0f04e52023-05-10WarningsExact identifier
spl id: f6c7ee2a-de64-46a9-9d94-f62987675c28
spl set id: 2c3e3a3c-d7f1-4893-9080-849fcf0f04e5

Reported adverse events (FAERS/openFDA)#

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