Label: SSS CLEANSER- sulfacetamide sodium and sulfur cream
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Contains inactivated NDC Code(s)
NDC Code(s): 42546-174-06, 42546-174-16 - Packager: PruGen Pharmaceuticals
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated January 20, 2022
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
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DESCRIPTION
Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Chemically sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:
Each mL of SSS 10-1 Cleanser (Sodium Sulfacetamide 10% & Sulfur 1%) contains 100 mg of Sulfacetamide Sodium, USP and 10 mg of Sulfur in a formulation consisting of: Aloe Barbadensis Leaf Juice, Butylated Hydroxy Toluene, Camellia Sinensis Leaf Extract, Cetyl Alcohol, Disodium Oleamido MEA Sulfosuccinate, Edetate Disodium, Glyceryl Stearate, Magnesium Aluminum Silicate, Methylparaben, PEG-100 Stearate, Propylene Glycol, Propylparaben, Purified Water, Sodium Cocoyl Isethionate, Sodium Methyl Cocoyl Taurate, Sodium Thiosulfate, Stearyl Alcohol, White Petrolatum, Xanthan Gum.
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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 acnes and the formation of free fatty acids.
- INDICATIONS
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CONTRAINDICATIONS
SSS 10-1 Cleanser (Sodium Sulfacetamide 10% & Sulfur 1%) is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. SSS 10-1 Cleanser (Sodium Sulfacetamide 10% & Sulfur 1%) is not to be used by patients with kidney disease.
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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 hemorrhagica, 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.
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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
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 and Impairment of Fertility
Long-term studies in animals have not been performed to evaluate carcinogenic potential.
PREGNANCY
Category C
Animal reproduction studies have not been conducted with SSS 10-1 Cleanser (Sodium Sulfacetamide 10% & Sulfur 1%). It is also not known whether SSS 10-1 Cleanser (Sodium Sulfacetamide 10% & Sulfur 1%) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. SSS 10-1 Cleanser (Sodium Sulfacetamide 10% & Sulfur 1%) should be given to a pregnant woman only if clearly needed.
NURSING MOTHERS
It is not known whether sodium sulfacetamide is excreted in the human milk following topical use of SSS 10-1 Cleanser (Sodium Sulfacetamide 10% & Sulfur 1%). 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 SSS 10-1 Cleanser (Sodium Sulfacetamide 10% & Sulfur 1%) is administered to a nursing woman.
- ADVERSE REACTIONS
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DOSAGE AND ADMINISTRATION
Apply SSS 10-1 Cleanser (Sodium Sulfacetamide 10% & Sulfur 1%) once or twice daily to affected areas, or as directed by your physician. Wet skin and liberally apply to areas to be cleansed. Massage gently into skin for 10-20 seconds, working into a full lather, rinse thoroughly and pat dry. If drying occurs, it may be controlled by rinsing off SSS 10-1 Cleanser (Sodium Sulfacetamide 10% & Sulfur 1%) sooner or using less often.
- HOW SUPPLIED
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 170.1 g Tube Carton
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INGREDIENTS AND APPEARANCE
SSS CLEANSER
sulfacetamide sodium and sulfur creamProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42546-174 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SULFACETAMIDE SODIUM (UNII: 4NRT660KJQ) (SULFACETAMIDE - UNII:4965G3J0F5) SULFACETAMIDE SODIUM 100 mg in 1 g SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 10 mg in 1 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) GREEN TEA LEAF (UNII: W2ZU1RY8B0) CETYL ALCOHOL (UNII: 936JST6JCN) DISODIUM OLEAMIDO MONOETHANOLAMINE SULFOSUCCINATE (UNII: 5M1101WGSY) EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) METHYLPARABEN (UNII: A2I8C7HI9T) PEG-100 STEARATE (UNII: YD01N1999R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493) SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G) SODIUM THIOSULFATE (UNII: HX1032V43M) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) PETROLATUM (UNII: 4T6H12BN9U) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42546-174-06 1 in 1 CARTON 11/15/2020 1 170.1 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:42546-174-16 1 in 1 CARTON 11/15/2020 2 453.6 g in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 11/15/2020 Labeler - PruGen Pharmaceuticals (929922750) Establishment Name Address ID/FEI Business Operations Dermazone Solutions, Inc. 136116865 MANUFACTURE(42546-174)
