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Claris Clarifying Wash

Generic Name: sulfacetamide sodium and sulfur
Dosage Form: topical emulsion

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

CLARIS™
CLARIFYING WASH

(Sodium Sulfacetamide 10% and Sulfur 4%)

Rx only

Claris Clarifying Wash Description

Each mL of CLARIS™ CLARIFYING WASH contains 100 mg of Sodium Sulfacetamide and 40 mg of Sulfur in an emulsion base containing Butylated Hydroxytoluene, Cetyl Alcohol, Disodium EDTA, Disodium Oleamido MEA Sulfosuccinate, Fragrance, Glyceryl Stearate and PEG 100 Stearate, Magnesium Aluminum Silicate, Methyl Paraben, Propyl Paraben, Purified Water, Sodium Cocoyl Isethionate, Sodium Methyl Cocoyl Taurate, Sodium Thiosulfate, Stearyl Alcohol, Urea 10% and Xanthan Gum.

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Sodium Sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Chemically, Sodium Sulfacetamide is N-{(4-aminophenyl)sulfony}-acetamide, monosodium salt, monohydrate.

The structural formula is:

Claris Clarifying Wash - Clinical Pharmacology

The most widely accepted mechanism of action of sulfonamides in 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 and Usage for Claris Clarifying Wash

CLARIS™ CLARIFYING WASH is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

Contraindications

CLARIS™ CLARIFYING WASH is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. CLARIS™ CLARIFYING WASH 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 out of reach of children. Keep bottle tightly closed.

Precautions

General

If irritation develops, use of the product should be discontinued and appropriate therapy instituted. Patients should be very carefully observed for possible local irritation or sensitization during 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.

Carcinogenesis, Mutagenesis an 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 CLARIS™ CLARIFYING WASH. It is also not known whether CLARIS™ CLARIFYING WASH can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. CLARIS™ CLARIFYING WASH 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 CLARIS™ CLARIFYING WASH. 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 CLARIS™ CLARIFYING WASH 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 ADMINISTERATION

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 treated, massage gently into skin for 10-20 seconds working into a full lather, rinse thoroughly and pat dry. If dying occurs, it may be controlled by rinsing wash off sooner or using less often.

How is Claris Clarifying Wash Supplied

CLARIS™ CLARIFYING WASH is available in 16 fl. oz. (473 mL) bottles, NDC 58980-335-90.

Store at controlled room temperature: 15°- 30° C (59°- 86° F)

Distributed by
STRATUS

PHARMACEUTICALS INC

Manufactured by
Sonar Products Inc.
Carlstadt, NJ 07072
for
Stratus Pharmaceuticals tnc.
12379 Southwest 130th Street
Miami, Florida 33186-6727

Customer Service
Telephone: 1-800-442-7882
Fax: 305-254-6875

©2008 Stratus Pharmaceuticals Inc.

Rev. CCW-IN200901.

PRINCIPAL DISPLAY PANEL - 473 mL Carton

NDC 58980-335-90

Rx only

CLARIS™

Clarifying
Wash

(Sodium Sulfacetamide 10%
and Sulfur Wash 4%)
In a Urea Vehicle

For Topical Use Only

STRATUS
PHARMACEUTICALS INC

Net WT. 16.0 fl. oz. (473 mL)

CLARIS 
sulfacetamide sodium and sulfur emulsion
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:58980-335
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SULFACETAMIDE SODIUM (SULFACETAMIDE) SULFACETAMIDE SODIUM 100 mg  in 1 mL
SULFUR (SULFUR) SULFUR 40 mg  in 1 mL
Product Characteristics
Color YELLOW (light yellow) Score     
Shape Size
Flavor Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:58980-335-90 1 BOTTLE (BOTTLE) in 1 BOX
1 473 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved other 02/16/2009
Labeler - Stratus Pharamceuticals, Inc (789001641)
Registrant - Sonar Products, Inc (104283945)
Establishment
Name Address ID/FEI Operations
Sonar Products, Inc 104283945 MANUFACTURE
Revised: 10/2009
 
Stratus Pharamceuticals, Inc
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