FDA Label for Hand And Wrist Pain Cream

View Indications, Usage & Precautions

Hand And Wrist Pain Cream 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



Histamine Dihydrochloride 0.025%


Keep Out Of Reach Of Children



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


Purpose



PURPOSE

Topical Analgesic


Uses



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


Warnings



For external use only. Do not use on wounds or damaged skin or if you are allergic to ingredients in this product. When using this product: avoid contact with eyes.  If product gets into eyes, rinse thoroughly with water.  Do not bandage tightly or use a heating pad.

Stop use and ask doctor if: rash appears.  Condition worsens. If symptoms persist for more than 7 days or if symptoms clear up and occur again within a few days.

If pregnant or breast feeding, ask a health professional before use.


Directions



​For Use by Adults and Children over 12 years.  ​Apply a thin layer to pain site and massage until thoroughly absorbed into skin.  Apply no more than 3 to 4 times daily.

Children 12 years or younger consult a physician


Inactive Ingredients



Aloe Barbadensis Leaf (Aloe Vera Gel), Aqua (Purified Water), Ascorbic Acid (Vitamin C), Butylene Glycol, Camellia Sinensis (Green Tea) Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Emu Oil, Ethylhexylglycerin, Ethylhexyl Stearate, Glycyrrhiza Glabra (Licorice) Root Extract, Helianthus Annuus (Sunflower) Seed Oil, C13-14 Isoparaffin, Laureth-7, Magnesium Sulfate, Methylsulfonylmethane (MSM), Phenoxyethanol, Polyacrylamide, Potassium Sorbate, Purica Granatum (Pomegranate) Extract, Saccharide Isomerate, Sodium Polyacrylate, Tochopheryl Acetate (Vitamin E), Trideceth-6, Vaccinium Angustifolium (Blueberry) Fruit Extract, Zemea (Corn) Propanediol


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Label




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