FDA Label for Sombra Cool Therapy
View Indications, Usage & Precautions
Sombra Cool 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 6%
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
Warnings
For external use only. Do not use on wounds or damaged skin. When using this product: avoid bandaging tightly, avoid contact with eyes, keep out of reach of children.
Stop use and ask doctor if: condition worsens, symptoms persist for more than 7 days, clear up and occur again within a few days.
Directions
adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily, rub in thoroughly until gel is absorbed,
children under 2 years of age: consult a doctor.
Inactive Ingredients
Aloe Barbadensis Leaf Juice, Camellia Sinensis (Green Tea) Leaf
Extract, Caprylyl Glycol, Carbomer, Citrus Grandis (Grapefruit) Seed Extract, Citrus Limon
(Lemon) Peel Oil, Decyl Glucoside, Glycerin, Hamamelis Virginiana (Witch Hazel) Leaf
Extract, Phenoxyethanol, Purified Water, Rosa Damascena Flower Water, Sodium Carbonate,
Spiraea Ulmaria Flower (Queen of the Prairie) Extract, Yucca Schidigera Root Extract.
Questions Or Comments
1-800-225-3963
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