Soraresal Cream
FDA Label NDC 73526-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Summer Herbal Inc. for the product Soraresal (NDC 73526-002). 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 drug facts, active ingredient, purpose, use, warnings, keep out of reach of children., directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Salicylic acid 2%
Purpose
Psoriasis
Use
for relief of the symptoms of psoriasis.
Warnings
For external use only.
Do not use
• on open wounds, nor infected, cracked skin.
• if you are sensitive or allergic to any of the ingredients used in this product.
Ask a doctor before use if you have a condition that covers a large area of the body.
When using this product
• avoid contact with the eyes and if contact occurs, rinse eyes thoroughly with water.
• avoid contact with the mouth, genitals and mucous membranes.
• avoid direct sunlight after use.
Stop use and ask a doctor if
• condition worsens or does not improve after regular use of this product as directed.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
• gently apply a layer to affected areas one to three times daily or as directed by a doctor.
• please allow the cream to stay in contact with your skin for as much time as possible to have full absorption before reapplying.
Other Information
Store in a cool dark place at room temperature 68°F.
Inactive Ingredients
Water (Aqua), Safflower (Carthamus tinctorius) Seed Oil, Banyan Tree (Ficus benghalensis) Bark Extract, Golden Shower Tree (Cassia fistula) Fruit Extract, Glyceryl Monostearate, Glycerin, Stearic Acid, Cetyl Palmitate, Polysorbate 80, Cetostearyl Alcohol, PEG-100 Stearate, Cetyl Alcohol, Coconut (Cocos nucifera) Oil, Triethanolamine, Phenoxyethanol, Ethylhexylglycerin, Dimethicone, Butylated Hydroxyanisole, Butylated Hydroxytoluene.
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