SULFUR FACIAL WASH ACNE CLEANSER- sulfur liquid 
GRISI Hnos, S.A DE C.V

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.

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Sulfur Facial Wash

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

Questions or comments/Dudas o comentarios

1-833-794-3320

Package Label

Package Label

SULFUR FACIAL WASH  ACNE CLEANSER
sulfur liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68437-012
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR3 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68437-012-84250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/08/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM00607/08/2019
Labeler - GRISI Hnos, S.A DE C.V (810320754)
Establishment
NameAddressID/FEIBusiness Operations
GRISI Hnos, S.A DE C.V810320754manufacture(68437-012)

Revised: 10/2022
Document Id: eb0475c6-c75a-55a1-e053-2a95a90a69e9
Set id: 8d6dfaf2-92ac-9a34-e053-2a95a90a9ca4
Version: 2
Effective Time: 20221014
 
GRISI Hnos, S.A DE C.V