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

Indication(s)

INDICATIONS: Sodium Sulfacetamide 10% Sulfur 5% Emollient Cream 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% Emollient Cream is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation.Sodium Sulfacetamide 10% Sulfur 5% Emollient Cream is not to be used by patients with kidney disease.
Adverse reactions
ADVERSE REACTIONS: Although rare, sodium sulfacetamide may cause local irritation.

Usage information

Dosing and administration
DOSAGE AND ADMINISTRATION: Cleanse skin thoroughly before application. Apply a thin layer to affected areas 1-3 times daily or as directed by a physician. To minimize potential dryness, start with one application daily, then gradually increase to 2-3 times daily as needed or as directed by a physician.
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% 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 Sodium Sulfacetamide 10% Sulfur 5% Emollient Cream is administered to a nursing woman.

More information

Category Value
Agency product number 70FD1KFU70
Orphan designation No
Product NDC 42192-139,42192-149
Date Last Revised 05-01-2018
Type HUMAN PRESCRIPTION DRUG
RXCUI 1005834
Storage and handling Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [see USP Controlled Room Temperature]
Marketing authorisation holder Acella Pharmaceuticals, LLC