Data from FDA - Curated by EPG Health - Last updated 31 August 2017

Indication(s)

INDICATIONS: Sodium Sulfacetamide 10% - Sulfur 5% Cleansing Cloths are 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% Cleansing Cloths are contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or ony other component of this preparation. Sodium Sulfacetamide 10% - Sulfur 5% Cleansing Cloths are 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 desqamation withour 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 vulfaris, 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 carcinogenesis potential. Pregnancy - Category C - Animal reproduction studies have not been conducted with Sodium Sulfacetamide 10% - Sulfur 5% Cleansing Cloths. It is not known whether Sodium Sulfacetamide 10% - Sulfur 5% Cleansing Cloths can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium Sulfacetamide 10% - Sulfur 5% Cleansing Cloths 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 Sodium Sulfacetamide 10% - Sulfur 5% Cleansing Cloths. 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% Cleansing Cloths are 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 area(s) with cleansing cloth once or twice daily, or as directed by your physician. Wet face with water. Wet cloth with a little water and work into a full lather. Cleanse face with cloth for 10-20 seconds, avoiding eyes. Rinse thoroughly and pat dry. Discard cloth. Do not flush.
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% Cleansing Cloths. 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% Cleansing Cloths are administered to a nursing woman.

More information

Category Value
Agency product number 70FD1KFU70
Orphan designation No
Product NDC 42192-138
Date Last Revised 09-08-2013
Type HUMAN PRESCRIPTION DRUG
RXCUI 1005819
Storage and handling Store at controlled room temperature, 20° - 25°C (68° - 77°F).
Marketing authorisation holder Acella Pharmaceuticals, LLC