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SSS Cleanser

Generic Name: sulfacetamide sodium and sulfur
Dosage Form: cream

Medically reviewed by Drugs.com. Last updated on Nov 1, 2020.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Rx Only

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA.

SSS Cleanser 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.

SSS Cleanser - 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

SSS 10-1 Cleanser (Sodium Sulfacetamide 10% & Sulfur 1%) is indicated for the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

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.

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.

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.

PEDIATRIC USE

Safety and effectiveness in children under the age of 12 has not been established.

Adverse Reactions

Although rare, sodium sulfacetamide may cause local irritation.

SSS Cleanser 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 is SSS Cleanser Supplied

SSS 10-1 Cleanser (Sodium Sulfacetamide 10% & Sulfur 1%) is available in a 6 oz. (170.1g) tube, NDC 42546-174-06.

Store at 20°C to 25°C (68°F to 77°F)

Protect from freezing.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Manufactured for:
PruGen Pharmaceuticals
Scottsdale, AZ 85255

Rev. 1.0

PRINCIPAL DISPLAY PANEL - 170.1 g Tube Carton

SSS
10-1
cleanser

Sodium
Sulfacetamide 10%
& Sulfur 1%

Rx only
Net Wt. 6 oz (170.1g)

NDC 42546-174-06

SSS Cleanser
sulfacetamide sodium and sulfur cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:42546-174
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SULFACETAMIDE SODIUM (SULFACETAMIDE) SULFACETAMIDE SODIUM 100 mg in 1 g
SULFUR (SULFUR) SULFUR 10 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
ALOE VERA LEAF
BUTYLATED HYDROXYTOLUENE
GREEN TEA LEAF
CETYL ALCOHOL
DISODIUM OLEAMIDO MONOETHANOLAMINE SULFOSUCCINATE
EDETATE DISODIUM
GLYCERYL MONOSTEARATE
MAGNESIUM ALUMINUM SILICATE
METHYLPARABEN
PEG-100 STEARATE
PROPYLENE GLYCOL
PROPYLPARABEN
WATER
SODIUM COCOYL ISETHIONATE
SODIUM METHYL COCOYL TAURATE
SODIUM THIOSULFATE
STEARYL ALCOHOL
PETROLATUM
XANTHAN GUM
Packaging
# Item Code Package Description
1 NDC:42546-174-06 1 TUBE in 1 CARTON
1 170.1 g in 1 TUBE
2 NDC:42546-174-16 1 BOTTLE in 1 CARTON
2 453.6 g in 1 BOTTLE
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 Operations
Dermazone Solutions, Inc. 136116865 MANUFACTURE(42546-174)
PruGen Pharmaceuticals

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