unknown creatures Clarifoam EF Generic Name: sulfur,sulfacetamide sodium Dosage Form: aerosol, foam Overview Side Effects Dosage Professional Interactions More User Reviews Support Group Q & A 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 Slideshow Acne Advice: Skin Care Solutions For Both Teens and Adults Alike 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 Next Interactions Print this page Add to My Med List More about Clarifoam EF (sulfacetamide sodium / sulfur topical) Side Effects Dosage Information Drug Interactions Support Group En Español 10 Reviews Add your own review/rating Drug class: topical antibiotics Consumer resources Clarifoam EF Professional resources Sodium Sulfactamide and Sulfur Wash (FDA) Other brands: Sumadan , Plexion , Sulfacleanse 8/4 , Sumaxin , ... +26 more Related treatment guides Rosacea Seborrheic Dermatitis Acne} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Drug Class Topical antibiotics Related Drugs topical antibiotics mupirocin topical , erythromycin topical , Bactroban , neomycin topical , gentamicin topical , bacitracin topical Rosacea doxycycline , metronidazole topical , brimonidine topical , Lotemax , MetroGel , Vibramycin , ivermectin topical , Finacea , More... Seborrheic Dermatitis prednisone , hydrocortisone topical , ketoconazole topical , dexamethasone , Decadron , Deltasone , ciclopirox topical , More... Acne doxycycline , clindamycin topical , erythromycin topical , minocycline , tretinoin topical , tetracycline , dapsone topical , More... Clarifoam EF Rating 10 User Reviews 8.3 /10 10 User Reviews 8.3 Rate it!} } as a result of
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