SULFUR FACIAL WASH ACNE CLEANSER- sulfur liquid

Sulfur Facial Wash by

Drug Labeling and Warnings

Sulfur Facial Wash by is a Otc medication manufactured, distributed, or labeled by GRISI Hnos, S.A DE C.V. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients/Ingredientes activos

Sulfur/Azufre 3%

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/Evite 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

Aqua, Sodium Laureth Sulfate, Acrylates Copolymer, Cocamidopropyl Betaine, Glycerin Aminomethyl Propanol, Phenoxyethanol, Sodium Chloride, Polysorbate 80, Coco Betaine, Lauroyl, Myristoyl Methyl Glucamide, Fragrance, Sorbeth-450 Triisostearate, Glycol Distearate, Disodium EDTA, Cocamide MEA, PEG-9 Cocoate, Laureth-10, Decylene Glycol, Caprylyl Glycol, PEG-32 Distearate, PEG-175 Distearate.

Questions or comments/Dudas o comentarios

833-794-3320/www.grisi.com o/or www.grisius.com/farmacoviglancia@grisi.com

Package Label

INGREDIENTS AND APPEARANCE

SULFUR FACIAL WASH  ACNE CLEANSER
sulfur liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68437-020
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
PEG-32 DISTEARATE (UNII: 5730584SOC)
PEG-175 DISTEARATE (UNII: 96X9M8B71Y)
EDETATE SODIUM (UNII: MP1J8420LU)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
WATER (UNII: 059QF0KO0R)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
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)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68437-020-84	250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/17/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	09/17/2024

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(68437-020)