Sodium Sulfacetamide Sulfur Cleansing Pads

Generic Name: sulfacetamide sodium and sulfur swab

Dosage Form: swab
Sodium Sulfacetamide 10% - Sulfur 4% Cleansing Pads In a vehicle containing Green Tea and Aloe 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) sulfonyl]-acetamide, monosodium salt, monohydrate.

The structural formula is:

Each pad of Sodium Sulfacetamide 10% - Sulfur 4% Cleansing Pads are coated with a cleanser-based formulation. Each gram of this cleanser-based

formulation contains 100 mg of Sodium Sulfacetamide and 40 mg of Sulfur. The cleanser base consists of: purified water, sodium cocoyl isethionate

disodium oleamido MEA sulfosuccinate, green tea extract, cetyl alcohol, stearyl alcohol, glycerol stearate and PEG 100 stearate methyl paraben, propyl

paraben, butylated hydroxytoluene, aloe vera gel, sodium thiosulfate, disodium EDTA, magnesium aluminum silicate, xanthan gum, sodium methyl cocoyl

taurate, white petrolatum.

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 not known, but it has been reported that it inhibits the growth of Propionibacterium acnes and the formation of free fatty acids.

INDICATIONS: Sodium Sulfacetamide 10% - Sulfur 4% Cleansing Pads are indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

CONTRAINDICATIONS: Sodium Sulfacetamide 10% - Sulfur 4% Cleansing Pads are contraindicated for use by patients having known hypersensitivity

to sulfonamides, sulfur or ony other component of this preparation. Sodium Sulfacetamide 10% - Sulfur 4% Cleansing Pads are not to be used by

patients with kidney disease.

WARNINGS: Although rare, sensitivity to sodium sulfacetaminde 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 irritaition 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.

PREGNANCY: Pregnancy Category C. Animal reproduction studies have not been conducted with Sodium Sulfacetamide 10% - Sulfur 4% Cleansing

Pads. It is not known whether Sodium Sulfacetamide 10% - Sulfur 4% Cleansing Pads can cause fetal harm when administered to a pregnant woman or

can affect reproduction capacity. Sodium Sulfacetamide 10% - Sulfur 4% Cleansing Pads 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 4% Cleansing Pads. 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 4% Cleansing Pads are

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 area(s) with cleansing pad once or twice dialy, or as directed by your physician. Wet area(s) with

water. Wet pad with a little water and work into a full lather. Cleanse area(s) with pad for 10-20 seconds, avoiding eyes. Rinse thoroughly and pat dry.

Discard pad. Do not flush.

HOW SUPPLIED: Sodium Sulfacetamide 10% - Sulfur 4% Cleansing Pads are available in boxes of 60 cloths (3.7 g), (NDC 42192-113-60).

Store at controlled room temperature, 15° - 25° (59° - 77°F).

All prescription substitutions using this product shall be made subject to state and federal statutes as applicable. Please note: this is not an Orange Book

product and has not been subjected to FDA therapeutic equivalency or other equivalency testing. Each person recommending a prescription substitution

using this product shall make such recommendations based on each such person’s professional opinion and knowledge, upon evaluating the active

ingredients, incipients, inactive ingredients and chemical formulation information provided herein.

MANUFACTURED FOR: Acella Pharmaceuticals, LLC

9005 Westside Parkway

Alpharetta, GA 30009

1-800-541-4802

Sodum Sulfacetamide 10%-

Sulfur 4% Cleansing Pads

In a vehicle containing Green Tea and Aloe

Rx Only

60 cleansing pads

Net wegith 3.7g each

Acella pharmaceuticals



Directions: Wash affected areas with Sodium Sulfacetamide 10% - Sulfur 4% once or twice daily or as direted by your physician.

1. Wet affected areas with water

2. Wet Sodium Sulfacetamide 10% - Sulfur 4% cleansing pad with water and work into a full lather.

3. Cleanse face with Sodium Sulfacetamide 10% - Sulfur 4% for 10 -20 seconds, avoiding eyes

4. Rinse thoroughly and pat dry

5. Discard pad. Do not flush.


Warnings for external use only. Keep out of reach of children. Avoid contact with eyes.


Indications: for the typical control of acne vulgaris and seborrheic dermatitis. See package insert for full prescribing information.


Contraindications: Sodium Sulfacetamide 10% - Sulfur 4% cleansing pads are contraindicated for use in patients having known hypersensitivity to sulfonamides, sulfur or anyother component of the preparation. Sodium Sulfacetamide 10% - Sulfur 4% cleansing pads are not to be used by patients with kidney disease.

 

Contents: Sodium Sulfacetamide 10% - Sulfur 4%. Other Ingredients: purified water, sodium cocoyl isethionate, disodium oleamido MEA sulfosuccinate, green tea extract, cetyl alcohol, stearyl alcohol, glycerol stearate and PEG 100 stearate methyl paraben, propyl paraben, butylated hydroxytoluene, aloe vera gel, sodium thiosufate, disodium EDTA, magnesium aluminum siliate, xanthan gum, sodium methyl cocoyl l-taurate, white petrolatum


Acella Pharmaceuticals


Store at 15 degrees to 25 degrees C or 59-77 degrees F)


All prescription substitutions and/or recommendations using this product shall be made subject to state and federal statutes as applicable. NOTE. This is not an Orange Book product. No representation is made as to generic status or bioequivalency. Please see package insert for more information.


Manufactured For:

Acella Pharmaceuticals, LLC

9005 Westside Parkway

Alpharetta, GA 30009

1-800-541-4802

SODIUM SULFACETAMIDE - SULFUR CLEANSING PADS  sodium sulfacetamide, sulfur  swab

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 42192-113 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SULFACETAMIDE SODIUM (SULFACETAMIDE) SULFACETAMIDE SODIUM 10 g  in 100 g SULFUR (SULFUR) SULFUR 4 g  in 100 g

Inactive Ingredients Ingredient Name Strength WATER   ALOE VERA LEAF   SODIUM THIOSULFATE   EDETATE DISODIUM   MAGNESIUM ALUMINUM SILICATE   XANTHAN GUM

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 42192-113-60 60 POUCH In 1 BOX contains a POUCH 1 3.7 g In 1 POUCH This package is contained within the BOX (42192-113-60)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		09/16/2010

Labeler - Acella Pharmaceuticals, LLC (825380939)

Revised: 12/2010Acella Pharmaceuticals, LLC

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