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| Product NDC Code | 73526-002 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Soraresal |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | CREAM | ||||||
| RxCUI drug identifier | 317152 | ||||||
| Application Number | M032 | ||||||
| Labeler Name | Summer Herbal Inc. | ||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Salicylic acid 2%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water (Aqua), Safflower ( Carthamus tinctorius ) Seed, Banyan Tree ( Ficus benghalensis ) Bark, Golden Shower Tree ( Cassia fistula ) Whole plant, Coconut ( Cocos nucifera ) Oil, Glycerin, Glyceryl Monostearate, Polysorbate 80, Cetostearyl Alcohol, Cetyl Palmitate, Stearic Acid, Cetyl Alcohol, Triethanolamine, Phenoxyethanol, Dimethicone, Butylated Hydroxyanisole, Butylated Hydroxytoluene.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Use for relief of the symptoms of psoriasis.
Purpose
Information about the drug product’s indications for use.Purpose Psoriasis
Spl product data elements
Usually a list of ingredients in a drug product.SORARESAL Salicylic Acid SALICYLIC ACID SALICYLIC ACID WATER SAFFLOWER OIL FICUS BENGHALENSIS BARK CASSIA FISTULA WHOLE COCONUT OIL GLYCERIN GLYCERYL MONOSTEARATE POLYSORBATE 80 CETOSTEARYL ALCOHOL CETYL PALMITATE STEARIC ACID CETYL ALCOHOL TROLAMINE PHENOXYETHANOL DIMETHICONE BUTYLATED HYDROXYANISOLE BUTYLATED HYDROXYTOLUENE
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Packaging SorSalcy-1 SorSalcy-2
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
FOR PSORIASIS with 2% Salicylic Acid • Controls Recurrence • Relieves Itching • Reduces Scaling • Dermo-Cosmetic • 100% Steroid-Free • No Added Fragrance Distributed by: SUMMER HERBAL INC., 510 Saint Johns Court, Oak Brook, IL 60523 You may report serious side effects to the above U.S. address. PRODUCT OF INDIA Soraresal Cream relieves itching, calms irritation and reduces scaling for easy relief from psoriasis. The active ingredient of 2% salicylic acid effectively makes your skin clear. Sustainably harvested plants, beautify and moisturize the skin with powerful oils. Control psoriasis easily with Soraresal. Manufactured for: Atrimed Pharmaceuticals Pvt. Ltd. Manufactured By: BioMylz Pvt. Ltd. at Building No. 1, # 21-D, 2nd Phase Peenya Industrial Area Bangalore, Karnataka 560058, India
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? 1-800-743-1718 Mon-Fri 9:00 A.M. - 5:00 P.M.
Storage and handling
Information about safe storage and handling of the drug product.Other information Store in a cool dark place at room temperature at 68°F - 77°F.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings For external use only. Do not use • on open wounds, infected or 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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API