Topisulf cream

Indications and usage:

Topisulf Emollient Creamis indicated for the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

Dosage and administration:

Apply Topisulf Emollient Creamto affected areas 1-3 times daily, or as directed by your doctor. First, cleanse your skin thoroughly before application. Second, apply a thin layer of Topisulf Emollient Creamto the affected areas as directed by your doctor. Finally, start using Topisulf Emollient Creamonce daily to minimize dryness, then increase application frequency to 2-3 times daily or as directed by your doctor.

Warnings and precautions:

Although rare, sensitivity to sodium sulfacetamide may occur. Therefore, caution and careful supervision should be observed when prescribing this drug for patients who may be prone to hypersensitivity to topical sulfonamides. Systemic toxic reactions such as agranulocytosis, acute hemolytic anemia, purpura hemorrhagica, drug fever, jaundice, and contact dermatitis indicate hypersensitivity to sulfonamides. Particular caution should be employed if areas of denuded or abraided skin are involved. Sulfonamides are known to cause Stevens-Johnson syndrome in hypersensitive individuals. Stevens-Johnson syndrome also has been reported following the use of sodium sulfacetamide topically. Cases of drug-induced systemic lupus erythematosus from topical sulfacetamide also have been reported. In one of these cases, there was a fatal outcome. In addition, patients with kidney disease should not use Topisulf Emollient Cream.

Topisulf Emollient Cream
is for external use only. Avoid contact with the eyes, eyelids, lips, other mucous membranes and any damaged areas of the skin, such as wounds or open sores. If accidental contact with one of these areas occurs, rinse thoroughly with water.

Keep out of the reach of children.

Adverse reactions:

Like any medication, Topisulf Emollient Creammay occasionally cause side effects in some people. Although uncommon, some possible side effects may include skin irritation such as redness, dryness, itching or swelling. If you experience excessive skin irritation, contact your doctor.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Use in specific populations:

Pregnancy: Category C. Animal reproduction studies have not been conducted with Topisulf Emollient Cream. It is also not known whether Topisulf Emollient Creamcan cause fetaI harm when administered to pregnant women or can affect reproduction capacity. Topisulf Emollient Creamshould be given to pregnant women only if clearly needed.

Nursing Mothers: It is not known whether sodium sulfacetamide is excreted in the human milk following topicaI use of Topisulf Emollient Cream. However, small amounts of orally administered sulfonamides have been reported to be eliminated in human milk. In view of this and because many drugs are excreted in human milk, caution should be exercised when Topisulf Emollient Creamis administered to nursing women.

Pediatric Use: Safety and effectiveness in children under the age of 12 have not been established.

Description:

Topisulf Emollient Creamcontains the following active ingredients: 10% Sodium Sulfacetamide and 5% Sulfur. Other inactive ingredients are Purified Water, Isopropyl Myristate NF, Propylene Glycol USP, Glyceryl Monostearate NF, Glyceryl Stearate and PEG 100 Stearate, Stearic Acid, Stearyl Alcohol and Ceteareth 20, Gum Arabic, Methylparaben, Disodium EDTA, Sodium Hyaluronate, Sodium Thiosulfate USP, Xanthan Gum, Baby Powder Fragrance, Propylparaben, Vitamin E Acetate, and Green Tea Extract.

Clinical pharmacology:

Sodium sulfacetamide: The bacteria fighting action helps to block the overgrowth of the bacteria thought to be involved in acne development. Sulfur: The exfoliating properties help to promote the removal of dead cells from the top layer of skin.

Nonclinical toxicology:

Carcinogenesis, Mutagenesis and Impairment of Fertility:Long-term studies in animals have not been performed to evaluate carcinogenic potential.

How supplied/storage and handling:

Topisulf Emollient Creamshould be stored between 2025C (6877F). Avoid exposing the products to excessive heat. Topisulf Emollient Creamis available in 1 oz tubes, NDC 49769-309-28.

Manufactured for:
Kylemore Pharmaceuticals
Port St. Joe, FL 32456
309-10 Rev. 02/10 P0558

Ingredients and appearance - Product information

Topisulf cream- Sulfacetamide sodium, sulfur

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 49769-309
Route of Administration Topical

Active Ingredient/Active Moiety

Ingredient Name Strength
Sulfacetamide sodium ( UNII: 4NRT660KJQ)( Sulfacetamide - UNII: 4965G3J0F5 ) 100 mgin 1 g
Sulfur ( UNII: 70FD1KFU70)( Sulfur - UNII: 70FD1KFU70 ) 50 mgin 1 g

Inactive Ingredients

Ingredient Name Code
Water ( UNII: 059QF0KO0R)
Isopropyl myristate ( UNII: 0RE8K4LNJS)
Propylene glycol ( UNII: 6DC9Q167V3)
Glyceryl monostearate ( UNII: 230OU9XXE4)
Glyceryl monostearate ( UNII: 230OU9XXE4)
Stearic acid ( UNII: 4ELV7Z65AP)
Stearyl alcohol ( UNII: 2KR89I4H1Y)
Acacia ( UNII: 5C5403N26O)
Methylparaben ( UNII: A2I8C7HI9T)
Edetate disodium ( UNII: 7FLD91C86K)
Hyaluronate sodium ( UNII: YSE9PPT4TH)
Sodium thiosulfate ( UNII: HX1032V43M)
Xanthan gum ( UNII: TTV12P4NEE)
Propylparaben ( UNII: Z8IX2SC1OH)
Alpha-tocopherol acetate ( UNII: 9E8X80D2L0)
Green tea leaf ( UNII: W2ZU1RY8B0)

Product Characteristics

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
unapproved drug other USA

Labeler - Kylemore Pharmaceuticals, LLC( 831892471)

Packaging:

Below represents the current packaging being used:

Tube:

Carton: