Soraresal
Salicylic Acid
Summer Herbal Inc.
Human Otc Drug
NDC 73526-002Soraresal also known as Salicylic Acid is a human otc drug labeled by 'Summer Herbal Inc.'. National Drug Code (NDC) number for Soraresal is 73526-002. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Soraresal drug includes Salicylic Acid - 2 g/100g . The currest status of Soraresal drug is Active.
Drug Information:
| Drug NDC: | 73526-002 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Soraresal |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Salicylic Acid |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Summer Herbal Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Cream |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | SALICYLIC ACID - 2 g/100g
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TOPICAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | OTC MONOGRAPH FINAL |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 01 Jan, 2020 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 10 May, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | part358H |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Summer Herbal Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 317152
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | O414PZ4LPZ
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 73526-002-02 | 1 BOTTLE in 1 BOX (73526-002-02) / 50 g in 1 BOTTLE | 01 Oct, 2021 | N/A | No |
| 73526-002-06 | 1 BOTTLE in 1 BOX (73526-002-06) / 191 g in 1 BOTTLE | 16 Sep, 2020 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose psoriasis
Product Elements:
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
Indications and Usage:
Use for relief of the symptoms of psoriasis.
Warnings:
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.
Dosage and Administration:
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.
Package Label Principal Display Panel:
Packaging sorsalcy-1 sorsalcy-2
Further Questions:
Questions or comments? 1-800-743-1718 mon-fri 9:00 a.m. - 5:00 p.m.