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  5. Label Information: Deep Core Pain Relieving Gel Warm Therapy

FDA Label for Deep Core Pain Relieving Gel Warm Therapy

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS
    2. PURPOSE
    3. KEEP OUT OF REACH OF CHILDREN
    4. USES
    5. WARNINGS
    6. DIRECTIONS
    7. INACTIVE INGREDIENTS
    8. QUESTIONS OR COMMENTS

Deep Core Pain Relieving Gel Warm Therapy Product Label

The following document was submitted to the FDA by the labeler of this product Sombra Cosmetics Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredients



Menthol USP 3%, Camphor 3%, Capsaicin 0.025%


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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