Sulfatol 10-4cleansing pads cloth

Description section

DESCRIPTION: Sodium sulfacetamide is a sulfacetamide with antibacterial activity while sulfur acts as a keratolytic agent. Chemically sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate.

Each pad of Sulfatol TM10-4 (sodium sulfacetamide 10% and sulfur 4%) Cleansing Padsis coated with a cleanser-based formulation contains 100mg of Sodium Sulfacetamide and 40mg of Sulfur. The cleanser base consists of: aloe, butylated hydroxytoluene, cetyl alcohol, disodium oleamido MEA sulfosuccinate, edetate disodium, fragrance, glycerin, glyceryl steartate/PEG-100 stearate, green tea, methylparaben, propylparaben, purified water, sodium cocoyl isethionate, sodium lauryl sulfoacetate, sodium thiosulfate, stearyl alcohol.

Clinical pharmacology section

CLINICAL PHARMACOLOGY: The most widely accepted mechanism of action of sulfonamides is the Woods-Fildes theory, which is based on the fact that sulfonamides act as competitive antagonists to para-aminobenzoic acid (PABA), an essential component for bacterial growth. While absorption through intact skin has not been determined, sodium sulfacetamide is readily absorbed from the gastrointestinal tract when taken orally and excreted in the urine, largely unchanged. The biological half-life has variously been reported as 7 to 12.8 hours. The exact mode of action of sulfur in the treatment of acne is unknown, but it has been reported that it inhibits the growth of Propionibacterium acnesand the formation of free fatty acids.

Indications & usage section

INDICATIONS: Sulfatol TM10-4 (sodium sulfacetamide 10% and sulfur 4%) Cleansing Padsare indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

Contraindications section

CONTRAINDICATIONS: Sulfatol TM10-4 (sodium sulfacetamide 10% and sulfur 4%) Cleansing Padsare contraindicated for the use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. Sulfatol TM10-4 (sodium sulfacetamide 10% and sulfur 4%) Cleansing Padsare not used by patients with kidney disease.

Warnings and precautions section

WARNINGS: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 hermorrhagica, drug fever, jaundice, and contact dermatitis indicate hypersensitivity to sulfonamides. Particular caution should be employed if areas of denuded or abraded skin are involved.

FOR EXTERNAL USE ONLY.Keep away from eyes. Keep out of reach of children. Keep container tightly closed.

Precautions section

PRECAUTIONS:General - If irritation develops, use of the product should be discontinued and appropriate therapy instituted. Patients should be carefully observed for possible local irritation or sensitization during long-term therapy. The object of this therapy is to achieve desquamation without irritation, but sodium sulfacetamide and sulfur can cause reddening and scaling of the epidermis. These side effects are not unusual in the treatment of acne vulgaris, but patients should be cautioned about the possibility.

Information for patients section

Information for Patients- Avoid contact with eyes, eyelids, lips and mucous membranes. If accidental contact occurs, rinse with water. If excessive irritation develops, discontinue use and consult your physician.

Carcinogenesis & mutagenesis & impairment of fertility section

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

Pregnancy section

PREGNANCY: Category C - Animal reproduction studies have not been conducted with Sulfatol TM10-4 (sodium sulfacetamide 10% and sulfur 4%) Cleansing Pads. It is also not know whether Sulfatol TM10-4 (sodium sulfacetamide 10% and sulfur 4%) Cleansing Padscan cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sulfatol TM10-4 (sodium sulfacetamide 10% and sulfur 4%) Cleansing Padsshould be given to a pregnant woman only if clearly needed.

I f pregnant, or planning to become pregnant or are currently breast-feeding please contact your physician, or health-care provider before using or continuing use.

Nursing mothers section

NURSING MOTHERS: It is not known whether sodium sulfacetamide is excreted in the human milk following topical use of Sulfatol TM10-4 (sodium sulfacetamide 10% and sulfur 4%) Cleansing Pads. However, small amounts of orally adminstered 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 Sulfatol TM10-4 (sodium sulfacetamide 10% and sulfur 4%) Cleansing Padsare administered to a nursing woman.

Pediatric use section

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

Adverse reactions section

ADVERSE REACTIONS: Although rare, sodium sulfacetamide may cause local irritation.

Dosage & administration section

DOSAGE AND ADMINISTRATION: Wash affected area(s) with cleansing pad once or twice daily, or as directed by your physician. Wet area(s) with water. Wet pad with a little water and work into a full lather. Cleanse area(s) with pad for 10-20 seconds, avoiding eyes. Rinse thoroughly and pat dry. Discard pad. Do not flush.

How supplied section


HOW SUPPLIED: Sulfatol TM10-4 (sodium sulfacetamide 10% and sulfur 4%) Cleansing Padsare available in boxes of 60 pads (3.7g), NDC 51991-697-99.

Store at 25C (77F); excursions permitted to 15 - 30C (59-86F). See USP Controlled Room Temperature. Protect from freezing.

Dispense in original container.

WARNING: KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CENTER IMMEDIATELY.

All prescription substitutions using this product shall be pursuant to state statues as applicable. This is not an Orange Book product.

Ingredients and appearance - Product information

Sulfatol 10-4cleansing pads cloth- Sodium sulfacetamide, sulfur

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 51991-697
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 ) 40 mgin 1 g

Inactive Ingredients

Ingredient Name Code
Aloe ( UNII: V5VD430YW9)
Butylated hydroxytoluene ( UNII: 1P9D0Z171K)
Cetyl alcohol ( UNII: 936JST6JCN)
Edetate disodium ( UNII: 7FLD91C86K)
Glycerin ( UNII: PDC6A3C0OX)
Glyceryl monostearate ( UNII: 230OU9XXE4)
Polyoxyl 100 stearate ( UNII: YD01N1999R)
Methylparaben ( UNII: A2I8C7HI9T)
Propylparaben ( UNII: Z8IX2SC1OH)
Water ( UNII: 059QF0KO0R)
Sodium lauryl sulfoacetate ( UNII: D0Y70F2B9J)
Sodium thiosulfate ( UNII: HX1032V43M)
Stearyl alcohol ( UNII: 2KR89I4H1Y)

Product Characteristics

Marketing Information

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

Labeler - Breckenridge Pharmaceutical inc.( 150554335)

Establishment

Name ID/FEI Business Operations
Breckenridge Pharmaceutical inc. 150554335 manufacture()

Package label.principal display panel