Sodium sulfacetamide is a sulfonamide with
antibacterial activity while sulfur acts as a keratolytic agent. Chemically
sodium sulfacetamide is N -[ (4-aminophenyl)suIfonyl]-acetamide, monosodium
salt, monohydrate. The structural formula is:
The most widely accepted mechanism of action of sulfonamides
is the Woods-Fildes theory which is based on the fact that sulfonamides act as
competitive antagonists to para-aminobenzoic acid (PABA), an essential
component for bacterial growth. While absorption through intact skin has not
been determined, sodium sulfacetamide is readily absorbed from the
gastrointestinal tract when taken orally and excreted in the urine, largely unchanged.
The biological half-life has variously been reported as 7 to 12.8 hours. The
exact mode of action of sulfur in the treatment of acne is unknown, but it has
been reported that it inhibits the growth of Propionibacterium acnes and
the formation of free fatty acids.
ROSANIL® Cleanser is indicated in the topical
control of acne vulgaris, acne rosacea and seborrheic dermatitis.
ROSANIL® Cleanser is contraindicated for use by
patients having known hypersensitivity to sulfonamides, sulfur or any other
component of this preparation. ROSANIL® Cleanser is not to be used by patients
with kidney disease.
Although rare, sensitivity to sodium
sulfacetamide may occur. Therefore, caution and careful supervision should be
observed when prescribing this drug for patients who may be prone to
hypersensitivity to topical sulfonamides. Systemic toxic reactions such as agranulocytosis,
acute hemolytic anemia, purpura hemorrhagica, drug fever, jaundice, and contact
dermatitis indicate hypersensitivity to sulfonamides. Particular caution should
be employed if areas of denuded or abraded skin are involved. FOR EXTERNAL USE ONLY. Keep away from eyes. Keep
out of reach of children. Keep container tightly closed.
General: It irritation develops, use of the
product should be discontinued and appropriate therapy instituted. Patients
should be carefully observed for possible local irritation or sensitization du
ring 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 ROSANIL® (sodium sulfacetamide 10% and sulfur 5%)
Cleanser. It is also not known whether ROSANIL® Cleanser can cause fetal harm
when administered to a pregnant woman or can affect reproduction capacity.
ROSANIL® Cleanser 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 ROSANIL®
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 ROSANIL® Cleanser
is administered to a nursing woman.Pediatric Use: Safety and effectiveness in
children under the age of 12 have not been established.
Although rare, sodium sulfacetamide may cause
DOSAGE AND ADMINISTRATION
Wash affected areas once or twice daily, or as directed by your physician, Avoid contact with eyes or mucous membranes. 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 cleanser off sooner or using less often.
ROSANIL® (sodium sulfacetamide 10% and sulfur
5%) Cleanser is available in a 6 oz tube. NDC
0299-3839-06 Store at controlled room temperature. 20o - 25 o C (68 o
- 77o F)
Marteted by: GALDERMA LABORATORIES, LP. Fort Worth. Texas 76177 USA Manufactured by: DPT Laboratories, Ltd. San Antonio, Texas 78215 USA
GALDERMA is a registered trademark. www.rosanil.com 325076-0706 Revised: July 2006