Label: SULFUR ointment
- NDC Code(s): 68437-010-01, 68437-010-20
- 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
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When using this product/Cuando use este producto
■ Skin irritation and dryness is more likely to occur if you use another topical medication at the same time. If irritation occursuse only one topical acne medication at a time/Se pueda presentar irritación ylo resequedad en la piel si se usa al mismo tiempo medicamento para el acné al mismo tiempo otro medicamento para el acne. Si esto ocurre, use solo medicamento para el acné.
■ 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
- 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
■ 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/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
- Questions or comments/Dudas o comentarios
- Package Label
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INGREDIENTS AND APPEARANCE
SULFUR
sulfur ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68437-010 Route of Administration TOPICAL 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 BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) DMDM HYDANTOIN (UNII: BYR0546TOW) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) LANOLIN (UNII: 7EV65EAW6H) LANOLIN ALCOHOLS (UNII: 884C3FA9HE) MENTHOL (UNII: L7T10EIP3A) METHYLPARABEN (UNII: A2I8C7HI9T) MINERAL OIL (UNII: T5L8T28FGP) OLEYL ALCOHOL (UNII: 172F2WN8DV) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PROPYLPARABEN (UNII: Z8IX2SC1OH) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SORBITAN MONOPALMITATE (UNII: 77K6Z421KU) TROLAMINE (UNII: 9O3K93S3TK) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68437-010-01 1 in 1 CARTON 12/01/2012 1 NDC:68437-010-20 20 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M006 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(68437-010)
