NDC 68437-012 Sulfur Facial Wash Acne Cleanser

Sulfur

NDC Product Code 68437-012

NDC Product Information

Sulfur Facial Wash Acne Cleanser with NDC 68437-012 is a a human over the counter drug product labeled by Grisi Hnos, S.a De C.v. The generic name of Sulfur Facial Wash Acne Cleanser is sulfur. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Grisi Hnos, S.a De C.v

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Sulfur Facial Wash Acne Cleanser Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • SULFUR 3 g/100mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • EDETIC ACID (UNII: 9G34HU7RV0)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • WATER (UNII: 059QF0KO0R)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 2600000 MW) (UNII: U1G23TFV1K)
  • BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)
  • AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • COCO MONOETHANOLAMIDE (UNII: C80684146D)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • COCO-BETAINE (UNII: 03DH2IZ3FY)
  • DECYLENE GLYCOL (UNII: S57M60MI88)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • GLYCOL DISTEARATE (UNII: 13W7MDN21W)
  • LAURETH-10 (UNII: BD7AST04GA)
  • LAUROYL/MYRISTOYL METHYL GLUCAMIDE (UNII: SC667B999P)
  • LIMONENE, (+)- (UNII: GFD7C86Q1W)
  • LINALOOL, (+)- (UNII: F4VNO44C09)
  • POLYETHYLENE GLYCOL 7000 (UNII: Q0JET65GEL)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • SODIUM LAURETH SULFATE (UNII: BPV390UAP0)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Grisi Hnos, S.a De C.v
Labeler Code: 68437
FDA Application Number: part333D What is the FDA Application Number?
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.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 07-08-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Sulfur Facial Wash Acne Cleanser Product Label Images

Sulfur Facial Wash Acne Cleanser Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredients/Ingredientes Activos

Sulfur/Azufre3%

Purpose/Utilidad

Acne treatment/Tratamiento para el acné

Uses/Usos

■ For the treatment of acne, helps clear up acne pimples/Para el tratamiento del acne, ayuda e eliminar espinillas del acne

Warnings/Precauciones

■ For external use only/Solo par uso externo■ Not for children under 12 years/No par ninos menores de 12 anos

Do Not Use/No User En

■ Broken skin/Heridas abiertas ■ Large areas of the skin/Grandes superficies de piel

When Using This Product/Cuando Use Este Producto

■ Avoid contact with the eyes. If product gets in the eyes rinse with water/Evire el contacto con los ojos. Si el producto entra en contacto con los ojos, enjuague con agua.

■ Apply only to the areas with acne/Aplique únicamente en áreas con acné

St Op Use And Ask A Doctor If/Suspenda Su Uso Y Consulte Al Medico Si

■ if skin irritation occurs or gets worse, stop use and consult a physician/Aparece alguna irritacion en la piel o esta empeora, suspenda su uso y consulte a su medico.

Keep Out Of The Reach Of Children

Mantengase fuera del alcance de los ninos

Directions/Modo De Uso

■ Clean the skin thoroughly before applying this product/Limpiar bien la piel antes de aplicar el producto. ■ Wet affected area with warm water/Humedecer la zona afectada con aqua tibia.■ Cover the entire affected area with a thin layer and massage until obtaining abundant lather. Leave for 1 minute and rinse thoroughly; one to three times a day/Cubrir el area afectada con una capa delgada y masajear hasta obtener espuma. Deja actuar por 1 minuto y enjuagar cuidadosamente; repetir de una a tres veces al dia ■ 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 día e incremente de los a tres veces al dia cuando sea necesario o segun las indicaciones del médico■ If bothersome dryness or peeling occurs, reduce application to once a day or every other day/Si aparece alguna resequedad o descamación, reduzca la aplicación a una vez al día o cada dos días

Inactive Ingredients/Ingredientes Inactivos

Acrylates Copolymer, Aminomethyl Propanol, Caprylyl Glycol, Cocamide MEA, Cocamidopropyl Betaine, Coco-Betaine, Decylene Glycol, Fragrance, Glycerin, Glycol Distearate, Laureth-10, Lauroyl/Myristoyl Methyl Glucamide, Limonene, Linalool, PEG-150, Phenoxyethanol, Polyquaternium-7, Polysorbate 80, Sodium Chloride, Sodium Laureth Sulfate, Tetrasodium EDTA, Water

* Please review the disclaimer below.

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