Clarifoam EF

Sulfacetamide sodium and sulfur are antibiotic that fight bacteria.

Sulfacetamide sodium and sulfur topical (for the skin) is a combination medicine used to treat acne, rosacea, and seborrheic dermatitis (a red, flaking skin rash).

Sulfacetamide sodium and sulfur topical may also be used for purposes not listed in this medication guide.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once if you have:

• new or worsening skin rash;

• joint pain;

• fever; or

• mouth sores.

Common side effects may include:

• redness, warmth, swelling, itching, stinging, burning, or irritation of treated skin.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

• If you have an allergy to sulfur, sulfacetamide, or any other part of Clarifoam EF (sulfur and sulfacetamide foam).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have a sulfa (sulfonamide) allergy, talk with your doctor.
• If you have kidney disease.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Clarifoam EF with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Clarifoam® EF Emollient Foam is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. Clarifoam® EF Emollient Foam is not to be used by patients with kidney disease.

General
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. 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.

It is not known whether sodium sulfacetamide is excreted in the human milk following topical use of Clarifoam® EF Emollient Foam. 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 Clarifoam® EF Emollient Foam is administered to a nursing woman.

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

Although rare, sodium sulfacetamide may cause local irritation.

Clarifoam® EF Emollient Foam is supplied in a 60g (NDC 16781-154-60) and 100g (NDC 16781-154-96) aluminum cans.

Will not dispense entire contents. Container is overfilled to guarantee dispensing at least the listed amount.

Store between 59° - 86°F (15° - 30°C). Protect from freezing. Store upright.

Manufactured for:

ONSET

DERMATOLOGICS

Cumberland, RI 02864
www.onsetdermatologics.com
(888)-713-8154

Patent Pending
P/N 2603

Rev. 8

Package/Label Display Panel – 5 g Carton

NDC 16781-154-06
Rx Only

Clarifoam® EF

EMOLLIENT FOAM
SODIUM SULFACTETAMIDE (10%), SULFUR (5%)

DELIVERED IN

Delevo

Foam

The Science of Compliance

For topical control of acne vulgaris, acne

rosacea, and seborrheic dermatitis
See prescribing information enclosed

ONSET

DERMATOLOGICS

LEAVE-ON
OR
WASH-OFF

Professional Samples

Enclosed: Six 5g Samples

Available in 60g and 100g Cans

NDC 16781-154-96
Rx Only

Clarifoam® EF

EMOLLIENT FOAM
SODIUM SULFACTETAMIDE (10%)

SULFUR (5%)

For topical control of acne

vulgaris, acne rosacea, and

seborrheic dermatitis

LEAVE-ON
OR
WASH-OFF

DELIVERED IN

Delevo

Foam

The Science of Compliance

Net Weight 100g

Will not dispense entire contents. Container is overfilled to

guarantee dispensing a minimum of 60 grams.

ONSET

DERMATOLOGICS