FDA Label for Capsaicin 0.1 Percent
View Indications, Usage & Precautions
Capsaicin 0.1 Percent Product Label
The following document was submitted to the FDA by the labeler of this product Alexso, 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 Ingredient
Capsaicin 0.1%
Purpose
External analgesic
Uses
Temporarily relieves minor aches and pains of muscles and joints due to:
• simple backache
• arthritis
• strains
• sprains
Warnings
For external use only
Read all warnings and directions before use. Test first on small area of skin.
Do Not Use
• On wounds or damaged skin
• If you are allergic to capsicum or chili peppers
When Using This Product
• You may experience a burning sensation. The intensity of this reaction varies among individuals and may be severe. With regular use, this sensation generally disappears after several days.
• Avoid contact with the eyes, lips, nose and mucous membranes
• Do not tightly wrap or bandage the treated area
• Do not apply heat to the treated area immediately before or after use
Stop Use And Ask A Doctor If
• Condition worsens or does not improve after regular use
• Severe burning persists or blistering occurs
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center immediately.
Directions
Adults and children 18 years of age and older:
Apply a thin film of cream to affected area and gently rub in until fully absorbed unless treating hands. Wash hands thoroughly with soap and water immediately after application for best results. Apply 3 to 4 times daily.
Children under 18 years: Ask a doctor
Other Information
Store at room temperature 15°-30°C (59°-86°F)
Inactive Ingredients
Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Cetearyl Alcohol, Chondroitin Sulfate, Ethylhexylglycerin, Glucosamine Sulfate, Glycerin, Glyceryl Stearate, C13-14 Isoparaffin, Isostearyl Palmitate, Laureth-7, Methylsufonylmethane (MSM), PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Propylene Glycol, Sodium Polyacrylate, Stearic Acid, and Triethanolamine
Principal Display Panel
Capsaicin 0.1% Cream
NDC 50488-1060-6
60 grams
Alexso, Inc
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