Each mL of Sodium Sulfacetamide 10% and Sulfur 5% Lotion (Tint Free) as dispensed contains 100 mg of sodium sulfacetamide and 50 mg of sulfur in a lotion of 2-bromo-2-nitropropane-1,3-diol, butylparaben, colloidal activated attapulgite, diethanolamine, hydroxyethyl cellulose, iron oxides, lauramide DEA, methylparaben, polyethylene glycol 400 monolaurate, propylene glycol, purified water, simethicone emulsion, sodium chloride, sodium metabisulfite, sodium polynaphthalenesulfonate, talc, xanthan gum, and zinc oxide.

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:

Last updated on RxList: 1/29/2009

Sodium Sulfacetamide 10% and Sulfur 5% Lotion (Tint Free) is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

Shake well before using. Apply a thin film to affected areas with light massaging, 1 to 3 times daily, or as directed by a physician.

(Important to the Pharmacist: At the time of dispensing, add contents of sodium sulfacetamide vial* to the bottle. Shake well and/or stir with a glass rod to insure uniform dispersion. Place expiration date of four (4) months on bottle label.)

*Sodium Sulfacetamide vial contains 2.1 g of sodium sulfacetamide.

Sodium Sulfacetamide 10% and Sulfur 5% Lotion (Tint Free) is available as follows:

25 g bottle (NDC 45802-950-01)

Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].

Manufactured by Stiefel Laboratories, Inc. Coral Gables, Fl 33134. Distributed by, Perrigo, Allegan, MI 49010. FDA rev date: n/a

Last updated on RxList: 1/29/2009

Although rare, sodium sulfacetamide may cause local irritation.

No information provided.

Last updated on RxList: 1/29/2009

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 bottle tightly closed.

Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

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 desquamation without irritation, but sodium sulfacetamide and sulfur can cause reddening and scaling of epidermis. These side effects are not unusual in the treatment of acne vulgaris, but patients should be cautioned about the possibility.

Carcinogenesis, Mutagenesis and Impairment of Fertility

Long-term studies in animals have not been performed to evaluate carcinogenic potential.

Pregnancy

Teratogenic Effects

Pregnancy Category C-Animal reproduction studies have not been conducted with Sodium Sulfacetamide 10% and Sulfur 5% Lotion (Tint Free). It is also not known whether this drug can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. This drug 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 Sodium Sulfacetamide 10% and Sulfur 5% Lotion (Tint Free). 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 this drug is administered to a nursing woman.

Pediatric Use

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

Last updated on RxList: 1/29/2009

No information provided.

Sodium Sulfacetamide 10% and Sulfur 5% Lotion (Tint Free) is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur, or any other component of this preparation. This drug is not to be used by patients with kidney disease.

Last updated on RxList: 1/29/2009

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.

Last updated on RxList: 1/29/2009

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

Last updated on RxList: 1/29/2009

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

SULFACETAMIDE/SULFUR LOTION - TOPICAL

(sull-fuh-SEET-uh-mide/SULL-fur)

COMMON BRAND NAME(S): Nicosyn, Novacet, Sulfacet-R

USES: This medication is used to help treat acne and other skin conditions (e.g., seborrheic dermatitis). This product contains an antibacterial agent and a drying agent which promotes shedding of the top layer of skin (keratolysis).

HOW TO USE: This medication is for use on the skin only. Some products should be shaken prior to use. Check your product labeling or ask your pharmacist to find out whether or not your product needs to be shaken before each use. Clean the affected area and apply a thin layer of medication to the skin 1 to 3 times daily, or use as directed by your doctor.

Avoid getting any of this medication in the eyes or inside the nose or mouth.

Inform your doctor if your condition does not improve or worsens.

SIDE EFFECTS: Redness and irritation of the skin may occur. If any of these effects persist or worsen, notify your doctor.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these serious side effects occur: cracked skin, rash.

Tell your doctor immediately if any of these unlikely but serious side effects occur: weakness, dark urine, yellowing eyes or skin, persistent sore throat, fever, easy bruising/bleeding.

You may be at increased risk for side effects if this medication is used on raw or broken skin. Consult your doctor for details.

An allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include: rash, itching, swelling, dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using sulfacetamide with sulfur, tell your doctor or pharmacist if you are allergic to it; or to other products containing sulfa or sulfur; or if you have any other allergies.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: kidney disease.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known whether the drugs in this product pass into breast milk when applied to the skin. Consult your doctor before breast- feeding.

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with them first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription products you may use, especially of: other skin products.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. This medicine may be harmful if swallowed.

NOTES: Do not share this medication with others.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature between 59 and 86 degrees F (15 to 30 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.