Label: SULFUR - sulfur soap 

  • NDC Code(s): 68437-011-44
  • Packager: GRISI Hnos, S.A DE C.V
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 11/12

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  • ACTIVE INGREDIENT

    Active Ingredients/Ingredientes Activos
    Sulfur/Azufre10%

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  • PURPOSE

    Purpose/Utilidad
    acne/acné

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  • INDICATIONS & USAGE

    Uses/Usos
    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

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  • WARNINGS

    Warnings/Avisos
    For external use only. Caution-if undue skin irritation develops or increases discontinue use and consult physician/Para uso externo solamente. Precaución: En caso de irritación de la piel, suspenda su uso y consulte a su médico
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  • WHEN USING

    When using this product/Alusaresteproducto

    •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 / Es más probable que ocurra irritación y sequeded en la piel si se utiliza otro medicamento para el acné al mismo tiempo. Si se produce irritación, utilice únicamente un medicamento para el acné a la vez

    •Apply only to the areas with acne/Aplique únicamente en áreas con acné
    Do not use/No lo use

    •Broken skin/Sobre heridas abiertas

    •Large areas of the skin /En áreas grandes de piel

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away/Mantener fuera del alcance de los ninos. En caso de ingestion, obtenga ayuda medica o contacte un centro de toxicologia de immediato. Close
  • DOSAGE & ADMINISTRATION

    Directions/DireccionesWet affected area with warm water. Apply soap and make abundant suds. Leave for 10 minutes. then rinse with cold water. Repeat 2 or 3 times daily or as directed by a doctor. Not for children under 12 years. Mojar la zona afectada con agua tibia. Aplicar el jabon y obtener espuma abundante. Dejar 10 minutos. Luego lave con agua fria. Repita 2 ó 3 veces al dia o seg

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  • INACTIVE INGREDIENT

    Inactive Ingredients: Sodium Tallowate, Sodium Cocoate, Corn (Zea Mays) Starch, Fragrance, Lanolin, Tetrasodium EDTA, Polysorbate 80.

    Ingredientes Inactivos: Sebato de sodio, Cocoato de Sodio, Almidon de Maiz (Zea mays), Fragancia, Lanolina, EDTA Tetrasodico, Polisorbato 80

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  • INGREDIENTS AND APPEARANCE
    SULFUR 
    sulfur soap
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:68437-011
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SULFUR (SULFUR) SULFUR 10 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    SODIUM TALLOWATE, BEEF  
    SODIUM COCOATE  
    STARCH, CORN  
    LANOLIN  
    EDETATE SODIUM  
    POLYSORBATE 80  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68437-011-44 125 g in 1 BOX
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333D 12/01/2012
    Labeler - GRISI Hnos, S.A DE C.V (810320754)
    Establishment
    Name Address ID/FEI Business Operations
    GRISI Hnos, S.A DE C.V 810320754 manufacture(68437-011)
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