Data from FDA - Curated by EPG Health - Last updated 09 February 2018

Indication(s)

INDICATIONS SSS 10 - 5 Emollient Foam is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

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Advisory information

contraindications
CONTRAINDICATIONS SSS 10 - 5 Emollient Foam is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. SSS 10 - 5 Emollient Foam is not to be used by patients with kidney disease.
Special warnings and precautions
PRECAUTIONS General The object of this therapy is to achieve desquamation without irritation, but sodium sulfacetamide and sulfur can cause reddening and scaling of the skin. These side effects are not unusual in the treatment of acne vulgaris, but patients should be cautioned about the possibility. 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. 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 - 5 Emollient Foam. When administered to a pregnant woman, it also is not known whether SSS 10 - 5 Emollient Foam can affect reproduction capacity or cause fetal harm. SSS 10 - 5 Emollient Foam should be given to a pregnant woman only if clearly needed. Nursing Mothers It is not known whether sodium sulfacetamide is excreted in human milk following topical use of SSS 10 - 5 Emollient Foam. However, small amounts of orally administered sulfonamides have been reported to be eliminated in human milk. Because many drugs are excreted in human milk, caution should be exercised when SSS 10 - 5 Emollient Foam is administered to a nursing woman. Pediatric Use Safety and effectiveness in children under the age of 12 have not been established.
Adverse reactions
ADVERSE REACTIONS Although rare, sodium sulfacetamide may cause local irritation.

Usage information

Dosing and administration
DOSAGE AND ADMINISTRATION Wash affected areas before use, 1 to 2 times daily as directed by physician. Before each use, shake can vigorously, then gently tap the bottom of the can on a firm surface or in palm of other hand. Tap can 1 - 2 times, then shake and tap again. Dispense can upright. Depress the actuator and dispense a small amount of foam (not more than a dollop the size of a golf ball). Pointing the can down will cause propellant loss. Wash affected areas and apply foam 1 or 2 times a day as directed by a physician. Avoid contact with the eyes. Wash-off Application: Massage the dispensed foam into the affected areas and wait 1 to 2 minutes. Rinse thoroughly with water and pat dry. Treat the affected area 1 to 2 times daily, as directed by a physician. Leave-on Application: Massage the foam into the affected areas 1 to 2 times daily, as directed by a physician. Wipe off any excess foam from actuator after use.
Pregnancy and lactation
Nursing Mothers It is not known whether sodium sulfacetamide is excreted in human milk following topical use of SSS 10 - 5 Emollient Foam. However, small amounts of orally administered sulfonamides have been reported to be eliminated in human milk. Because many drugs are excreted in human milk, caution should be exercised when SSS 10 - 5 Emollient Foam is administered to a nursing woman.

More information

Category Value
Agency product number 70FD1KFU70
Orphan designation No
Product NDC 42192-143
Date Last Revised 06-02-2018
Type HUMAN PRESCRIPTION DRUG
Marketing authorisation holder Acella Pharmaceuticals, LLC