Clarifoam EF

Generic Name: sulfur,sulfacetamide sodium
Dosage Form: aerosol, foam

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.

Clarifoam EF
EMOLLIENT FOAM
FOR EXTERNAL USE ONLY
Rx Only

Clarifoam EF 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 gram of Clarifoam® EF (sodium sulfacetamide 10% and sulfur 5%) Emollient Foam contains 100 mg of sodium sulfacetamide and 50 mg of sulfur in an aqueous based emollient foam vehicle containing cetyl alcohol NF, emulsifying wax NF, lactic acid USP, methylparaben NF, propylene glycol USP, propylparaben NF, steareth-10, water USP. Also contains: Propellant HFA-134A (1,1,1,2-tetrafluoroethane).

Clarifoam EF - Clinical Pharmacology

Sodium sulfacetamide exhibits antibacterial activity. 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.

It is estimated that 1% of topically applied sulfur is absorbed. Although the exact mode of keratolytic activity of sulfur is unknown, it is reported to result from the interaction of sulfur with the cysteine content of keratinocytes. In combination with sulfacetamide, sulfur has been reported to inhibit the growth of Propionibacterium acnes thereby reducing the associated inflammation.

INDICATIONS

Clarifoam® EF Emollient Foam is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

Contraindications

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.

Warnings

Although rare, hypersensitivity reactions to products containing sodium sulfacetamide may occur, including Stevens-Johnson syndrome and exfoliative dermatitis. 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 the reach of children. Contents under pressure. Do not puncture or incinerate container. Do not expose to temperatures above 120ºF (49ºC).

Precautions

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.

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 Clarifoam® EF Emollient Foam. It is also not known whether Clarifoam® EF Emollient Foam can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Clarifoam® EF Emollient Foam 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 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.

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.

Clarifoam EF Dosage and Administration

IMPORTANT: Prime Can Before Initial Use.
To Prime Can: Shake can well (until product moves inside can). Firmly strike bottom of can onto palm of hand at least 3 times. Hold can upright and direct initial spray to a non-skin surface. Until foam dispenses, DO NOT spray directly on the skin as the initial spray may expel cold liquid propellant. Press down on actuator for 1 to 3 seconds until foam begins to dispense. If foam does not dispense within 3 seconds, prime can again.
WASH-OFF APPLICATION: Cleanse affected skin thoroughly and pat dry before each application. Holding can upright, dispense Clarifoam® EF into palm of hand. Massage the dispensed foam into the affected area and wait 10 minutes. Rinse thoroughly with water and pat dry. Treat the affected area 1 to 3
times daily, or as directed by a physician. Wipe off any excess foam from actuator after use.
LEAVE-ON APPLICATION: Cleanse affected skin thoroughly and pat dry before each application. Holding can upright, dispense Clarifoam® EF into the palm of hand. Massage the dispensed foam into the affected area 1 to 3 times daily, or as directed by a physician. Wipe off any excess foam from actuator after use.

How is Clarifoam EF Supplied

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

Package/Label Display Panel – 60 g Carton

NDC 16781-154-60
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 60g

Will not dispense entire contents. Container is overfilled to

guarantee dispensing a minimum of 60 grams.

ONSET

DERMATOLOGICS

Package/Label Display Panel – 100 g Carton

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

Clarifoam EF 
sulfur,sulfacetamide sodium aerosol, foam
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:16781-154
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SULFUR (SULFUR) SULFUR 5 g  in 100 g
SULFACETAMIDE SODIUM (SULFACETAMIDE) SULFACETAMIDE SODIUM 10 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
CETYL ALCOHOL  
LACTIC ACID  
METHYLPARABEN  
PROPYLENE GLYCOL  
PROPYLPARABEN  
STEARETH-10  
WATER  
Packaging
# Item Code Package Description
1 NDC:16781-154-06 5 g in 1 CAN
2 NDC:16781-154-60 60 g in 1 CAN
3 NDC:16781-154-96 100 g in 1 CAN
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 06/01/2007 07/31/2015
Labeler - Onset Dermatologics LLC (793223707)
Registrant - Onset Dermatologics LLC (964275155)
Establishment
Name Address ID/FEI Operations
Onset Dermatologics LLC 793223707 MANUFACTURE(16781-154)
Revised: 06/2011
 
Onset Dermatologics LLC
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