Active Ingredients
Menthol USP 3%, Camphor 3%, Capsaicin 0.025%
Deep Core Pain Relieving Gel Warm Therapy
FDA Label NDC 61577-2800
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 Deep Core Pain Relieving Gel Warm Therapy (NDC 61577-2800). 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, purpose, keep out of reach of children, 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
Purpose
Purpose
External Analgesic
Keep Out Of Reach Of Children
Keep out of reach of children
Uses
Temporarily relieves minor aches and pains of muscles and joints associated with: arthritis, simple backaches, arthritis, sprains, strains, and bruises.
Warnings
For external use only. Do not use on wounds, damaged, broken, or irritated skin. Do not bandage tightly or apply heating pads or medicated patch to the area of use. If pregnant or breast feedong, ask a healthcare professional before use. Keep out of reach of children and pets.
Directions
Adults 18 years and above: Apply thin layer to the affected area not more than 3-4 times daily. Massage until cream absorbs into skin. Wash hands with water and soap after application. Adults and children 2 - 18 years of age consult a doctor before use. Children aged under 2, do not use.
Inactive Ingredients
Aloe Barbadensis Leaf Juice, Arnica Montana Extract, Camellia Sinensis Leaf Extract, Carbomer, Citrus Aurantium Dulcis (orange) Peel Oil, Citrus Grandis (Grapefruit) Fruit Extract, Decyl Glucoside, Dimethyl Isosorbide, Ethylhexylglycerin, Glucosamine Sulfate, Glycerin, Methylsulfonylmethane (MSM), Phenoxyethanol, Polysorbate 20, Purified Water, Pyridoxine Hydrochloride (Vitamin B6), Sodium Carbonate, Tocopheryl Acetate, Vernonia Amygdalina (Bitter Leaf) Extract, Witch Hazel Extract.
Questions Or Comments
505-492-4611
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