ROSANIL® Cleanser

ROSANIL CLEANSER - sulfacetamide sodium and sulfur lotion 
DPT Laboratories, Ltd.

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ROSANIL® Cleanser

ROSANIL® Cleanser

(sodium sulfacetamide 10% and sulfur 5%)
Rx Only

DESCRIPTION

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:

Sodium-Sulfacetamide-Structural-Formula-01

Each gram of ROSANlL® (sodium sulfacetamide 10% and sulfur 5%) Cleanser contains: Active: sodium sulfacetamide 10% (100 mg), sulfur 5% (50 mg). Inactive: butylated hydroxytoluene, edentate disodium, emulsifying wax, hydrochloric acid, light mineral oil, methylparaben, PPG-2 hydroxyethyl coco/isostearamide, propylparaben, purified water, sodium cocoyl isethionate, sodium lauryl sulfoacetate (and) disodium laureth sulfosuccinate, and sodium thiosulfate.

CLINICAL PHARMACOLOGY

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.

INDICATIONS

ROSANIL® Cleanser is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

CONTRAINDICATIONS

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.

WARNINGS

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.

PRECAUTIONS

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.

ADVERSE REACTIONS

Although rare, sodium sulfacetamide may cause local irritation.

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.

HOW SUPPLlED

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)

Galderma-logo-01


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

ROSANIL® Cleanser, 6 oz.

Rx Only   NDC 0299-3839-06

Rosanil
(Sodium Sulfacetamide 10%,
sulfur 5%)
CLEANSER

NET WT.
6 oz
(170 g)

GALDERMA

Rosanil-tube-6oz-01
Rosanil-carton-6oz-01

ROSANIL  CLEANSER
sodium sulfacetamide and sulfur   lotion
Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)63094-3839
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SULFACETAMIDE SODIUM (SULFACETAMIDE) SULFACETAMIDE SODIUM100 mg  in 1 g
SULFUR (SULFUR) SULFUR50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
163094-3839-61 BOTTLE In 1 CARTONcontains a BOTTLE, PLASTIC
1170 g In 1 BOTTLE, PLASTICThis package is contained within the CARTON (63094-3839-6)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other12/30/200205/05/2011

Labeler - DPT Laboratories, Ltd. (832224526)
Revised: 05/2011DPT Laboratories, Ltd.