NDC 79043-180 Clenia Plus Sodium Sulfacetamide - Sulfur

Sulfacetamide Sodium And Sulfur

NDC Product Code 79043-180

NDC CODE: 79043-180

Proprietary Name: Clenia Plus Sodium Sulfacetamide - Sulfur What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Sulfacetamide Sodium And Sulfur What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Product Characteristics

Color(s):
YELLOW (C48330)

NDC Code Structure

  • 79043 - Scite Pharma, Llc

NDC 79043-180-08

Package Description: 237 mL in 1 BOTTLE

NDC Product Information

Clenia Plus Sodium Sulfacetamide - Sulfur with NDC 79043-180 is a a human prescription drug product labeled by Scite Pharma, Llc. The generic name of Clenia Plus Sodium Sulfacetamide - Sulfur is sulfacetamide sodium and sulfur. The product's dosage form is suspension and is administered via topical form.

Labeler Name: Scite Pharma, Llc

Dosage Form: Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Clenia Plus Sodium Sulfacetamide - Sulfur Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • SULFACETAMIDE SODIUM 90 mg/mL
  • SULFUR 42.5 mg/mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • ALOE (UNII: V5VD430YW9)
  • AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)
  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • GUAR GUM (UNII: E89I1637KE)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM THIOSULFATE (UNII: HX1032V43M)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
  • TRIACETIN (UNII: XHX3C3X673)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Sulfonamide Antibacterial - [EPC] (Established Pharmacologic Class)
  • Sulfonamides - [CS]

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Scite Pharma, Llc
Labeler Code: 79043
Marketing Category: UNAPPROVED DRUG OTHER - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 03-10-2021 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Clenia Plus Sodium Sulfacetamide - Sulfur Product Label Images

Clenia Plus Sodium Sulfacetamide - Sulfur Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

NDC 79043-180-08Rx OnlyTopical Suspension in a vehicle containing Green Tea and AloeFOR EXTERNAL USE ONLYNOT FOR OPHTHALMIC USESHAKE WELLNet Wt. (8oz) 237 mLActive ingredients: Sodium Sulfacetamide 9% and Sulfur 4.25%Indications: For the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.Directions: Shake Well before using. Apply once or twice daily to affected areas, or as directed by your physician. Wet skin and liberally apply to areas to be cleansed. Massage gently into skin for 10-20 seconds, working into a full lather, rinse thoroughly and pat dry. If drying occurs, it may be controlled by rinsing off sooner or using less often.See enclosed package insert for full prescribing information.Warnings: For external use only. Not for ophthalmic use.Avoid contact with eyes or mucous membranes.KEEP OUT OF REACH OF CHILDREN. Keep bottle tightly closed.Store at controlled room temperature, 15° - 30°C (59° - 86°F). Protect from freezing.Manufactured for:          Manufactured in U.S.A Scite Pharma, LLCCanton, MS 39046           Rev. 01/2021Clenia Plus(Sodium Sulfacetamide 9%-Sulfur 4.25% Suspension)For External Use Only. Not for Ophthalmic use.Rx Only

Manufactured for:Scite Pharma, LLCCanton, MS 39046Manufactured in U.S.ARev. 01/2021All prescriptions using this product shall be made subject to state and federal statutes as applicable. NOTE: this is not an Orange Book product and has not been subjected to FDA therapeutic equivalency or other equivalency testing.

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 mL contains 90 mg of sodium sulfacetamide and 42.5 mg of sulfur in vehicle consisting of aloe vera gel, ammonium lauryl sulfate, butylated hydroxytoluene, cetyl alcohol, cocamidopropyl betaine, disodium EDTA, glycerin, glyceryl stearate SE, green tea extract, guar gum, methylparaben, PEG 100 stearate, propylene glycol, propylparaben, purified water, sodium thiosulfate, stearyl alcohol, and triacetin.

Clinical Pharmacology

Sodium sulfacetamide exerts a bacteriostatic effect against sulfonamide sensitive Gram-positive and Gram-negative microorganisms commonly isolated from secondary cutaneous pyogenic infections. It acts by restricting the synthesis of folic acid required by bacteria for growth, by its competition with para-aminobenzoic acid. There is no clinical data available on the degree and rate of systemic absorption of this product when applied to the skin or scalp. However, significant absorption of sodium sulfacetamide through the skin has been reported.The following in vitro data is available but the clinical significance is unknown. Organisms that show susceptibility to sodium sulfacetamide are: Streptococci, Staphylococci, E. coli, Klebsiella pneumoniae, Pseudomonas pyocyanea, Salmonella species, Proteus vulgaris, Nocardia and Actinomyces.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.

Indications

Clenia Plus (Sodium Sulfacetamide 9% - Sulfur 4.25% Suspension) is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

Contraindications

Clenia Plus is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. Clenia Plus is not to be used by patients with kidney disease.

Warnings

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.Sulfonamides are known to cause Stevens-Johnson syndrome in hypersensitive individuals. Stevens-Johnson syndrome also has been reported following the use of sodium sulfacetamide topically. Cases of drug-induced systemic lupus erythematosus from topical sulfacetamide also have been reported. In one of these cases, there was a fatal outcome.FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.Avoid contact with eyes, lips and mucous membranes.KEEP OUT OF REACH OF CHILDREN. Keep container tightly closed.

General

Nonsusceptible organisms, including fungi, may proliferate with the use of this preparation. 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. Systemic absorption of topical sulfonamides is greater following application to large, infected, abraded, denuded or severely burned areas. Under these circumstances, any of the adverse effects produced by the systemic administration of these agents could potentially occur, and appropriate observations and laboratory determinations should be performed.The object of this therapy is to achieve desquamation without 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 vulgaris, but patients should be cautioned about the possibility.

Information For Patients

Avoid contact with eyes, lips and mucous membranes. Patients should discontinue the use of this product if the condition becomes worse or if a rash develops in the area being treated or elsewhere. The use of this product should also be discontinued promptly and the physician notified if any arthritis, fever or sores in the mouth develop.

Drug Interactions

This product is incompatible with silver preparations.

Carcinogenesis, Mutagenesis And Impairment Of Fertility

Long-term studies in animals have not been performed to evaluate carcinogenic potential. Studies on reproduction and fertility also have not been performed. Chromosomal nondisjunction has been reported in the yeast, Saccharomyces cerevisiae, following application of sodium sulfacetamide. The significance of this finding to the topical use of sodium sulfacetamide in the human is unknown.

Category C

Animal reproduction studies have not been conducted with Clenia Plus. It is not known whether Clenia Plus can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Clenia Plus should be given to a pregnant woman only if clearly needed or when potential benefits outweigh potential hazards to the fetus.

Nursing Mothers

It is not known whether this drug is excreted in the human milk. 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 Clenia Plus is administered to a nursing woman.

Pediatric Use

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

Adverse Reactions

Reports of irritation and hypersensitivity to sodium sulfacetamide are uncommon. The following adverse reactions, reported after administration of sterile ophthalmic sodium sulfacetamide, are noteworthy: instances of Stevens-Johnson syndrome and instances of local hypersensitivity which progressed to a syndrome resembling systemic lupus erythematosus; in one case a fatal outcome was reported (see WARNINGS).Call your doctor for medical advice about side effects. To report SUSPECTED ADVERSE REACTIONS or obtain product information, contact Scite Pharma, LLC at 1-866-633-9033 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Overdosage

The oral LD 50 of sulfacetamide in mice is 16.5 g/kg. In the event of overdosage, emergency treatment should be started immediately.

Manifestations

Overdosage may cause nausea and vomiting. Large oral overdosage may cause hematuria, crystalluria and renal shutdown due to the precipitation of sulfa crystals in the renal tubules and the urinary tract. For treatment, contact your local Poison Control Center (1-800-222-1222), or your doctor.

Dosage And Administration

SHAKE WELL before use. Cleanse affected areas. Apply Clenia Plus once or twice daily to affected areas, or as directed by your physician. Wet skin and liberally apply to areas to be cleansed. Massage gently into skin for 10-20 seconds, working into a full lather, rinse thoroughly and pat dry. If skin dryness occurs, it may be controlled by rinsing off Clenia Plus sooner or using less often.

How Supplied

Clenia Plus (Sodium Sulfacetamide 9% - Sulfur 4.25% Suspension) is available in 8 fl oz (237 mL) bottles, NDC 79043-180-08 and 1 fl oz (30mL) samples, NDC 79043-180-99.

Storage And Handling

Store at controlled room temperature, 15° - 30°C (59° - 86°F). Protect from freezing.KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

* Please review the disclaimer below.