Label: SULFUR FACIAL WASH ACNE CLEANSER- sulfur liquid
- NDC Code(s): 68437-012-84
- 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
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- Official Label (Printer Friendly)
- Active Ingredients/Ingredientes activos
- Purpose/Utilidad
- Uses/Usos
- Warnings/Precauciones
- Do not use/No user en
- When using this product/Cuando use este producto
- St op use and ask a doctor if/Suspenda su uso y consulte al medico si
- Keep out of the reach of children
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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
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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
- Questions or comments/Dudas o comentarios
- Package Label
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INGREDIENTS AND APPEARANCE
SULFUR FACIAL WASH ACNE CLEANSER
sulfur liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68437-012 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 3 g in 100 mL Inactive Ingredients Ingredient Name Strength EDETATE SODIUM (UNII: MP1J8420LU) SODIUM CHLORIDE (UNII: 451W47IQ8X) WATER (UNII: 059QF0KO0R) AMINOMETHYLPROPANOL (UNII: LU49E6626Q) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 2600000 MW) (UNII: U1G23TFV1K) BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E) 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68437-012-84 250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/08/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M006 07/08/2019 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(68437-012)
