Data from FDA - Curated by EPG Health - Last updated 27 July 2017

Indication(s)

INDICATIONS CLENIA® (sodium sulfacetamide 10% and sulfur 5%) Foaming Wash and CLENIA® (sodium sulfacetamide 10% and sulfur 5%) Emollient Cream are indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

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Advisory information

contraindications
CONTRAINDICATIONS CLENIA® Foaming Wash and CLENIA® Emollient Cream are contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of these preparations. CLENIA® Foaming Wash and CLENIA® Emollient Cream are not to be used by patients with kidney disease.
Special warnings and precautions
PRECAUTIONS General Although the object of this therapy is to achieve desquamation without irritation, this product poses a low potential for irritation, which may include reddening and scaling of the epidermis. Uncommon adverse reactions such as dryness, erythema, itching and edema may occur. Therefore, patients should be monitored for possible local irritation or sensitization. Use of the product should be discontinued if excessive irritation develops. 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 Pregnancy Category C Animal reproduction studies have not been conducted with CLENIA® (sodium sulfacetamide 10% and sulfur 5%) Foaming Wash or CLENIA® (sodium sulfacetamide 10% and sulfur 5%) Emollient Cream. It is not known whether CLENIA® Foaming Wash and CLENIA® Emollient Cream can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. CLENIA® Foaming Wash and CLENIA® Emollient Cream should be used during pregnancy only if the potential benefit outweighs the potential risk. Nursing Mothers It is not known whether sodium sulfacetamide is excreted in human milk following topical use of CLENIA® Foaming Wash and CLENIA® Emollient Cream. However, small amounts of orally administered sulfonamides have been detected in human milk. In view of this and because many drugs are excreted in human milk, caution should be exercised when CLENIA® Foaming Wash and CLENIA® Emollient Cream 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, adverse reactions such as dryness, erythema, itching and edema have been reported.

Usage information

Dosing and administration
DOSAGE AND ADMINISTRATION CLENIA® Foaming Wash Wash affected areas once or twice daily or as directed by a physician. Wet skin, apply liberally and massage gently into skin for 10-20 seconds working into a full later. Rinse thoroughly and pat dry. Avoid contact with eyes and mucous membranes. If drying occurs, reduce cleansing time and rinse product off sooner or use less often. CLENIA® Emollient Cream 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 human milk following topical use of CLENIA® Foaming Wash and CLENIA® Emollient Cream. However, small amounts of orally administered sulfonamides have been detected in human milk. In view of this and because many drugs are excreted in human milk, caution should be exercised when CLENIA® Foaming Wash and CLENIA® Emollient Cream is administered to a nursing woman.

More information

Category Value
Agency product number 70FD1KFU70
Orphan designation No
Product NDC 0245-0168,0245-0169
Date Last Revised 02-09-2009
Type HUMAN PRESCRIPTION DRUG
RXCUI 1189036
Storage and handling Store at 15-25°C (59-77°F). Avoid excessive heat.
Marketing authorisation holder Upsher-Smith Laboratories, Inc