Zencia Wash

Stratus Pharamceuticals, Inc

ZENCIA WASH

FULL PRESCRIBING INFORMATION: CONTENTS*

• ZENCIA WASH DESCRIPTION
• CLINICAL PHARMACOLOGY
• INDICATIONS
• ZENCIA WASH CONTRAINDICATIONS
• WARNINGS
• PRECAUTIONS
  • General
  • Information for Patients
  • Carcinogenesis, Mutagenesis and Impairment of Fertility
  • PREGNANCY
  • NURSING MOTHERS
  • PEDIATRIC USE
• ZENCIA WASH ADVERSE REACTIONS
• ZENCIA WASH DOSAGE AND ADMINISTRATION
• HOW SUPPLIED
• PRINCIPAL DISPLAY PANEL - 473 mL Carton

FULL PRESCRIBING INFORMATION

(sodium sulfacetamide 9% & sulfur 4%)

In a vehicle containing Green Tea & Aloe

ZENCIA WASH DESCRIPTION

Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolyic agent. Chemically sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]- acetamide, monosodium salt monohydrate. The structural formula is:

Each mL of ZENCIA ^™ WASH contains 90 mg of Sodium Sulfacetamide and 40 mg of Sulfur in a formulation consisting of: Aloe, Butylated Hydroxytoluene, Cetyl Alcohol, Disodium Oleamido MEA Sulfosuccinate, Edetate Disodium, Fragrance, Glyceryl Stearate and PEG 100 Stearate, Green Tea, Magnesium Aluminum Silicate, Methyl Paraben, Propyl Paraben, Purified Water, Sodium Cocoyl Isethionate, Sodium Methyl Cocoyl Taurate, Sodium Thiosulfate, Stearyl Alcohol and Xanthan Gum.

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

ZENCIA ^™ WASH (sodium sulfacetamide 9% & sulfur 4%) is indicated for the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

ZENCIA WASH CONTRAINDICATIONS

ZENCIA ^™ WASH (sodium sulfacetamide 9% & sulfur 4%) are contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. ZENCIA ^™ WASH (sodium sulfacetamide 9% & sulfur 4%) 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

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 dequamation 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 ZENCIA ^™ WASH (sodium sulfacetamide 9% & sulfur 4%). It is also not known whether ZENCIA ^™ WASH (sodium sulfacetamide 9% & sulfur 4%) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. ZENCIA ^™ WASH (sodium sulfacetamide 9% & sulfur 4%) 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 ZENCIA ^™ WASH (sodium sulfacetamide 9% & sulfur 4%). 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 ZENCIA ^™ WASH (sodium sulfacetamide 9% & sulfur 4%) is administered to a nursing woman.

PEDIATRIC USE

Safety and effectiveness in children under the age of 12 have not been established.

ZENCIA WASH ADVERSE REACTIONS

Although rare, sodium sulfacetamide may cause local irritation.

ZENCIA WASH DOSAGE AND ADMINISTRATION

Apply ZENCIA ^™ WASH (sodium sulfacetamide 9% & sulfur 4%) once or twice daily to affected areas, or as directed by your physician. 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 off ZENCIA ^™ WASH (sodium sulfacetamide 9% & sulfur 4%) sooner or using less often.

HOW SUPPLIED

ZENCIA ^™ WASH (sodium sulfacetamide 9% & sulfur 4%) is available in a 16 oz. bottle, NDC 58980-336-90.

Store at 25°C (77°F); excursion permitted to 15°C - 30°C (59° - 86°F). Protect from Freezing. [See USP Controlled Room Temperature].

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Manufactured by:
Sonar Products Inc.
Carlstadt, NJ 07072

Manufactured for:
Stratus Pharmaceuticals Inc
Miami, Florida 33186-6727
Telephone: 800-442-7882
www.stratuspharmaceuticals.com

ZWI - 201006

PRINCIPAL DISPLAY PANEL - 473 mL Carton

NDC 58980-336-90

Rx only

For Topical Use Only

ZENCIA ^™
WASH

(Sodium Sulfacetamide 9%
and Sulfur Wash 4%)
in a vehicle containing
Green Tea and Aloe

Distributed by:
STRATUS
PHARMACEUTICALS INC

Net WT. 16.0 oz. (473 mL)