Data from FDA - Curated by EPG Health - Last updated 25 January 2018

Indication(s)

INDICATIONS: Sodium Sulfacetamide 10% - Sulfur 5% Cleanser is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

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Advisory information

contraindications
CONTRAINDICATIONS: Sodium Sulfacetamide 10% - Sulfur 5% Cleanser is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. Sodium Sulfacetamide 10% - Sulfur 5% Cleanser is not to be used by patients with kidney disease.
Special warnings and precautions
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 Sodium Sulfacetamide 10% - Sulfur 5% Cleanser. It is not known whether Sodium Sulfacetamide 10% - Sulfur 5% Cleanser can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium Sulfacetamide 10% - Sulfur 5% Cleanser should be given to a pregnant woman only if clearly needed.
Adverse reactions
ADVERSE REACTIONS: Although rare, sodium sulfacetamide may cause local irritation.

Usage information

Dosing and administration
DOSAGE AND ADMINISTRATION: Apply Sodium Sulfacetamide 10% - Sulfur 5% Cleanser 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 Sodium Sulfacetamide 10% - Sulfur 5% Cleanser sooner or using less often.
Pregnancy and lactation
NURSING MOTHERS: It is not known whether sodium sulfacetamide is excreted in the human milk following topical use of Sodium Sulfacetamide 10% - Sulfur 5% Cleanser. 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 Sodium Sulfacetamide 10% - Sulfur 5% Cleanser is administered to a nursing woman.

More information

Category Value
Agency product number 70FD1KFU70
Orphan designation No
Product NDC 42192-136
Date Last Revised 05-01-2018
Type HUMAN PRESCRIPTION DRUG
Storage and handling Store at 15° - 25°C (59° - 77°F). Protect from freezing.
Marketing authorisation holder Acella Pharmaceuticals, LLC