Indications and uses
■ 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
■ 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
■ 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, leave for 1 minute and rinse thoroughly with cold water; one to three times a day/Cubrir el area afectada con una capa delgada, dejar actuar por 1 minuto y enjuagar con agua fria...
Sulfur/Azufre10%
Acne treatment/Tratamiento para el acne
■ 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
■ For external use only/ Solo para uso externo
■ Not for children under 2 years/No para ninos menores de 12 anos
■ Broken skin/Heridas abiertas
■ Large areas of the skin/Grandes superficies de piel
■ 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 / Se puede presentar irritación ylo resequedad en la piel si se usa al mismo tiempo otro medicamento para el acné. Si esto ocurre, use un solo medicamento para el acné
■ Apply only to the areas with acne/Aplique únicamente en áreas con acné
■ If skin irritation occurs or gets worse, stop use and consult physician/ Aparece alguna irritacion en la piel o esta empeora, suspenda su uso y consulte a su medico
Mantengase fuera del alcance de los ninos.
■ 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, leave for 1 minute and rinse thoroughly with cold water; one to three times a day/Cubrir el area afectada con una capa delgada, dejar actuar por 1 minuto y enjuagar con agua fria; 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
Corn starch, Fragrance, Lanolin, Polysorbate 80, Sodium Cocoate, Sodium Lauryl sulfate, Sodium Tallowate,Tetrasodium EDTA
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| SULFUR | ACTIVE INGREDIENT | 70FD1KFU70 | 1 | |
| SULFUR | ACTIVE MOIETY | 70FD1KFU70 | 1 | |
| EDETATE SODIUM | INACTIVE INGREDIENT | MP1J8420LU | 1 | |
| LANOLIN | INACTIVE INGREDIENT | 7EV65EAW6H | 1 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | 1 | |
| SODIUM COCOATE | INACTIVE INGREDIENT | R1TQH25F4I | 1 | |
| SODIUM TALLOWATE, BEEF | INACTIVE INGREDIENT | 07RIK6QMEW | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 68437-011 | 68437-011-44, 68437-011-01 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SODIUM TALLOWATE, BEEF | 07RIK6QMEW | IACT |
| SODIUM COCOATE | R1TQH25F4I | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| LANOLIN | 7EV65EAW6H | IACT |
| EDETATE SODIUM | MP1J8420LU | IACT |
| POLYSORBATE 80 | 6OZP39ZG8H | IACT |
| SULFUR | 70FD1KFU70 | ACTIB |
| SODIUM LAURYL SULFATE | 368GB5141J | IACT |
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | POWDER, FOR SUSPENSION / ORAL | 396 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION, POWDER, FOR SUSPENSION / INTRAMUSCULAR | 4 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 900 mg | ||
| SODIUM TALLOWATE, BEEF | SODIUM TALLOWATE, BEEF | 07RIK6QMEW | SOAP / TOPICAL | 80 %w/w | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION, SUSPENSION / INTRAVENOUS | 0.5 %w/v | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | SUSPENSION / ORAL | 900 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | DROPS / AURICULAR (OTIC) | 0.02 %w/w | ||
| EDETATE SODIUM | EDETATE SODIUM | MP1J8420LU | SOLUTION / TOPICAL | 0.3 %w/w | ||
| EDETATE SODIUM | EDETATE SODIUM | MP1J8420LU | SOLUTION / OPHTHALMIC | 0.1 %w/v | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | CAPSULE, DELAYED RELEASE / ORAL | 23 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | CAPSULE / ORAL | 418.37 mg | ||
| EDETATE SODIUM | EDETATE SODIUM | MP1J8420LU | TABLET / ORAL | 5 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET / ORAL | 1116 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | TABLET, EXTENDED RELEASE / ORAL | 10 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | TABLET / SUBLINGUAL | 0.08 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | GEL / TOPICAL | 12 mg | ||
| EDETATE SODIUM | EDETATE SODIUM | MP1J8420LU | INJECTION, SOLUTION / INTRAVENOUS | 0.04 %w/v | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | SUPPOSITORY / RECTAL | 72.15 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | SYSTEM / TOPICAL | 28 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | PASTE / ORAL | 28 mg | ||
| LANOLIN | LANOLIN | 7EV65EAW6H | CREAM / TOPICAL | 10 mg | ||
| EDETATE SODIUM | EDETATE SODIUM | MP1J8420LU | SPONGE / TOPICAL | 0.14 %w/w | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | AEROSOL, FOAM / VAGINAL | 3 %w/w | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | DROPS / ORAL | NA | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR | 1 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | TABLET / ORAL | 233 mg | ||
| EDETATE SODIUM | EDETATE SODIUM | MP1J8420LU | EMULSION / OPHTHALMIC | 0.02 %w/v | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | SOLUTION/ DROPS / OPHTHALMIC | 0.25 %w/v | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | CAPSULE, COATED PELLETS / ORAL | 2 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | TABLET, DELAYED RELEASE / ORAL | 4 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION, SUSPENSION / INTRAMUSCULAR | 4 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | CREAM / TOPICAL | 20 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 8 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | TABLET, FILM COATED / ORAL | 24 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | CONCENTRATE / ORAL | NA | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | ELIXIR / ORAL | 2.5 mg/15ml | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | SUSPENSION / AURICULAR (OTIC) | 1 %w/v | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | SUSPENSION, EXTENDED RELEASE / ORAL | 113 mg | ||
| LANOLIN | LANOLIN | 7EV65EAW6H | SHAMPOO / TOPICAL | 2 %w/w | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | LIQUID / INTRAVENOUS | 720 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | SOLUTION / OPHTHALMIC | 8 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | SUSPENSION / ORAL | 206 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET / BUCCAL | 16.6 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | CAPSULE, COATED / ORAL | 0.04 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | CAPSULE / ORAL | 5785 mg | ||
| LANOLIN | LANOLIN | 7EV65EAW6H | LOTION / TOPICAL | 1.5 %w/w | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | CAPSULE, EXTENDED RELEASE / ORAL | 10 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | DROPS / OPHTHALMIC | 0.05 %w/w | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION, SOLUTION, CONCENTRATE / INTRAVENOUS | 4739 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | EMULSION / TOPICAL | 34050 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION / INTRASYNOVIAL | 0.2 %w/v | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | SUSPENSION, EXTENDED RELEASE / ORAL | 40 mg | ||
| EDETATE SODIUM | EDETATE SODIUM | MP1J8420LU | INJECTION / INTRAMUSCULAR | 0.01 %w/v | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | INSERT / VAGINAL | 147 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION / INTRAMUSCULAR | 4 %w/v | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, DELAYED RELEASE / ORAL | 713 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | LOTION / TOPICAL | 15 %w/w | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION, SUSPENSION / SUBCUTANEOUS | 0.3 %w/v | ||
| EDETATE SODIUM | EDETATE SODIUM | MP1J8420LU | CAPSULE / ORAL | 1 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | CAPSULE, LIQUID FILLED / ORAL | 24 mg |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| eb044ac3-0b3a-0ec2-e053-2995a90a1c8b | e5a73a0b-b84e-4da0-905d-3d6b81da9dee | 2022-10-14 | Warnings | eb044ac3-0b3a-0ec2-e053-2995a90a1c8b e5a73a0b-b84e-4da0-905d-3d6b81da9dee |
Adverse event summaries are temporarily unavailable. Other product information remains available.