Active Ingredients
Camphor 3%, Capsaicin 0.025%, Methyl Salicylate 10%, Menthol 3%
Australian Dream Power 4 Muscle And Joint Pain Relief Cream
FDA Label NDC 61577-8220
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 Power 4 Muscle And Joint Pain Relief Cream (NDC 61577-8220). 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 and pets., 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 And Pets.
If swallowed, get medical help or contact a Poison Control Center right away
Purpose
Topical Analgesic
Uses
For temporary relief of minor aches and pains of muscles and joints associated with arthritis, simple backache, strains, sprains, and bruises.
Warnings
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
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
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?
Call 1-888-600-4642
* Please review the disclaimer below.
