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Sulfur by GRISI Hnos, S.A DE C.V

Dosage form: ointment
Ingredients: SULFUR 10g in 100g
Labeler: GRISI Hnos, S.A DE C.V
NDC Code: 68437-010

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 FACTS

Active Ingredients/Ingredientes Activos
Sulfur/Azufre10%

Purpose/Utilidad
Acne treatment/Tratamiento para el acné

Uses/Usos
For the treatment of acne/Para el uso del acne
dries and clears acne pimples and allows skin to heal/seca y limpia las espinillas del acne y permite que la piel sane
helps prevent new acne pimples from forming/ayuda a prevenir la nueva formación de espinillas del 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/Direcciones
clean the skin thoroughly before applying this product/limpiar bien la piel antes de aplicar este producto
cover the entire affected area with a thin layer one to three times daily/cubrir toda él área afecteda con una capa delgada 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/ya que un exceso de sequedad en la piel pudiera ocurrir, comience con una aplicación diaria poco a poco aumentar a dos o tres veces al día si es necesario o segứn las indicaciones del médico if bothersome dryness or peeling occurs, reduce application to once a day or every other day/si la sequedad molesta o existe descamación, reduzca la aplicación a una vez al día o cada dos días

Inactive Ingredients: BHT, Carbomer, Cetearyl Alcohol, Decyl olivate, DMDM Hydantoin, Fragrance, Isopropyl Myristate, Lanolin, Lanolin Alcohol, Menthol, Methylparaben, Mineral Oil, Oleyl Alcohol, Polysorbate 80, Propylene Glycol, Propylparaben, Sorbitan Palmitate, Triethanolamone, Water/Ingredientes Inactivos: BHT, Carbớmero, Alcohol cetearílico, Decil olivato, Hidantoína DMDM, Fragancia, Miristato de isopropilo, Lanolina, Alcohol de lanolina, Mentol, Metilparabeno, Aceite mineral, Alcohol oleilo, Polisorbato 80, Propilenglicol, Propilparabeno, Palmitato de sorbitán, Trietanolamina, Agua purificada

SULFUR 
sulfur ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68437-010
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SULFUR (SULFUR) SULFUR10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYTOLUENE 
CETOSTEARYL ALCOHOL 
DMDM HYDANTOIN 
ISOPROPYL MYRISTATE 
LANOLIN 
LANOLIN ALCOHOLS 
MENTHOL 
METHYLPARABEN 
MINERAL OIL 
OLEYL ALCOHOL 
POLYSORBATE 80 
PROPYLPARABEN 
PROPYLENE GLYCOL 
SORBITAN MONOPALMITATE 
TROLAMINE 
WATER 
Packaging
#Item CodePackage Description
1NDC:68437-010-011 TUBE (TUBE) in 1 CARTON
1NDC:68437-010-2020 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D12/01/2012
Labeler - GRISI Hnos, S.A DE C.V (810320754)
Establishment
NameAddressID/FEIOperations
GRISI Hnos, S.A DE C.V810320754manufacture(68437-010)

Revised: 11/2012
 
GRISI Hnos, S.A DE C.V

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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