Active Ingredient
Capsaicin 0.035%
Capsaicin 0.035 Percent Cream
FDA Label NDC 50488-1035
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Alexso, Inc for the product Capsaicin 0.035 Percent (NDC 50488-1035). 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 ingredient, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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 0.035% cream
NDC 50488-1035-1
100 grams
Alexso, Inc
Capsaicin 0.035% Creamndc 50488-1035-1100 Gramsalexso, Inc (Capsaicin 0 035 Percent Cream 01)
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