Label: SULFUR soap
- NDC Code(s): 68437-011-01, 68437-011-44
- Packager: GRISI Hnos, S.A DE C.V
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 October 14, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients/Ingredientes Activos
- Purpose/Utilidad
- Uses/Usos
- Warnings/Precauciones
- Do not use/No usar en
-
When using this product/Cuando use este producto
■ 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
■ Apply only to the areas with acne/Aplique únicamente en áreas con acné
- Stop use and ask a doctor if/Suspenda su uso y consulte al medico si
- Keep out of the reach of children
-
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, 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
■ 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 ingredientes/Ingredientes inactivos
- Package Label
-
INGREDIENTS AND APPEARANCE
SULFUR
sulfur soapProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68437-011 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 10 g in 100 g Inactive Ingredients Ingredient Name Strength SODIUM TALLOWATE, BEEF (UNII: 07RIK6QMEW) SODIUM COCOATE (UNII: R1TQH25F4I) STARCH, CORN (UNII: O8232NY3SJ) LANOLIN (UNII: 7EV65EAW6H) EDETATE SODIUM (UNII: MP1J8420LU) POLYSORBATE 80 (UNII: 6OZP39ZG8H) SODIUM LAURYL SULFATE (UNII: 368GB5141J) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68437-011-44 125 g in 1 BOX; Type 0: Not a Combination Product 12/01/2012 2 NDC:68437-011-01 30 g in 1 BOX; Type 0: Not a Combination Product 06/03/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M006 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)
