SULFUR - sulfur soap 
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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DRUG FACTS

Active Ingredients/Ingredientes Activos
Sulfur/Azufre10%

Purpose/Utilidad
acne/acné

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

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

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

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.

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

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

image description

SULFUR 
sulfur soap
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68437-011
Route of Administration TOPICAL DEA Schedule     
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)  
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)

Revised: 11/2012
Document Id: 054206cd-c5ee-41c2-a2d8-6cde28fcb08b
Set id: e5a73a0b-b84e-4da0-905d-3d6b81da9dee
Version: 1
Effective Time: 20121121
 
GRISI Hnos, S.A DE C.V