Sulfur
Grisi Hnos, S.a De C.v
Human Otc Drug
NDC 68437-011Sulfur is a human otc drug labeled by 'Grisi Hnos, S.a De C.v'. National Drug Code (NDC) number for Sulfur is 68437-011. This drug is available in dosage form of Soap. The names of the active, medicinal ingredients in Sulfur drug includes Sulfur - 10 g/100g . The currest status of Sulfur drug is Active.
Drug Information:
| Drug NDC: | 68437-011 |
| 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: | Sulfur |
| 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: | Sulfur |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Grisi Hnos, S.a De C.v |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Soap |
| 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: | SULFUR - 10 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 Dec, 2012 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 08 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: | M006 |
| 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: | GRISI Hnos, S.A DE C.V
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 313147
|
| 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. |
| UPC: | 0037836084225
|
| UPC stands for Universal Product Code. |
| UNII: | 70FD1KFU70
|
| 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 |
|---|
| 68437-011-01 | 30 g in 1 BOX (68437-011-01) | 03 Jun, 2019 | N/A | Yes |
| 68437-011-44 | 125 g in 1 BOX (68437-011-44) | 01 Dec, 2012 | 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/utilidad acne treatment/tratamiento para el acne
Product Elements:
Sulfur sulfur sodium tallowate, beef sodium cocoate starch, corn lanolin edetate sodium polysorbate 80 sulfur sulfur sodium lauryl sulfate
Indications and Usage:
Uses/usos â for the treatment of acne, helps clears acne up acne blemishes and pimples/para el tratamiento del acne, ayuda a eliminar y espinillas de acne
Warnings:
Warnings/precauciones â for external use only/ solo para uso externo â not for children under 2 years/no para ninos menores de 12 anos
Do Not Use:
Warnings/precauciones â for external use only/ solo para uso externo â not for children under 2 years/no para ninos menores de 12 anos
When Using:
When using this product/cuando use este producto â skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. if irritation occurs, only use one topical acne medication at a time / se puede presentar irritación ylo resequedad en la piel si se usa al mismo tiempo otro medicamento para el acné. si esto ocurre, use un solo medicamento para el acné â apply only to the areas with acne/aplique únicamente en áreas con acné
Dosage and Administration:
Directions/modo de uso â clean the skin thoroughly before applying this product/limpiar bien la piel antes de aplicar el producto. â wet affected area with warm water/humedecer la zona afectada con aqua tibia. â cover the entire affected area with a thin layer, leave for 1 minute and rinse thoroughly with cold water; one to three times a day/cubrir el area afectada con una capa delgada, dejar actuar por 1 minuto y enjuagar con agua fria; repetir de una a tres veces al dia â because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor/debido a que puede ocurrir un exceso de resequedad en la piel, comience con una aplicación al dÃa e incremente de los a tres veces al dia cuando sea necesario o segun las indicaciones del médico â if bothersome dryness or peeling occurs, reduce application to once a day or every other day/si aparece alguna resequed
Read more...ad o descamación, reduzca la aplicación a una vez al dÃa o cada dos dÃas
Stop Use:
Stop use and ask a doctor if/suspenda su uso y consulte al medico si â if skin irritation occurs or gets worse, stop use and consult physician/ aparece alguna irritacion en la piel o esta empeora, suspenda su uso y consulte a su medico
Package Label Principal Display Panel:
Package label package label