NDC 70156-108 Sodium Sulfacetamide 10%, Sulfur 2%

Sodium Sulfacetamide, Sulfur

NDC Product Code 70156-108

NDC CODE: 70156-108

Proprietary Name: Sodium Sulfacetamide 10%, Sulfur 2% 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: Sodium Sulfacetamide, 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.

NDC Code Structure

  • 70156 - Noble Pharmaceuticals, Llc
    • 70156-108 - Sodium Sulfacetamide 10%, Sulfur 2%

NDC 70156-108-08

Package Description: 227 g in 1 BOTTLE

NDC Product Information

Sodium Sulfacetamide 10%, Sulfur 2% with NDC 70156-108 is a a human prescription drug product labeled by Noble Pharmaceuticals, Llc. The generic name of Sodium Sulfacetamide 10%, Sulfur 2% is sodium sulfacetamide, sulfur. The product's dosage form is solution and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1000895.

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

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.

Sodium Sulfacetamide 10%, Sulfur 2% 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.


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 VERA LEAF (UNII: ZY81Z83H0X)
  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
  • CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • DISODIUM OLEAMIDO MEA-SULFOSUCCINATE (UNII: 5M1101WGSY)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)
  • SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)
  • SODIUM THIOSULFATE (UNII: HX1032V43M)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
  • XANTHAN GUM (UNII: TTV12P4NEE)

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: Noble Pharmaceuticals, Llc
Labeler Code: 70156
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: 02-06-2018 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.

Sodium Sulfacetamide 10%, Sulfur 2% Product Label Images

Sodium Sulfacetamide 10%, Sulfur 2% 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

Rx OnlyFOR EXTERNAL USE ONLY.NOT FOR OPHTHALMIC USE.

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 the 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: Category C. Animal reproduction studies have not been conducted with Sodium Sulfacetamide 10% and Sulfur 2% Cleanser. It is also not known whether Sodium Sulfacetamide 10% and Sulfur 2% Cleanser can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium Sulfacetamide 10% and Sulfur 2% Cleanser 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 2% Cleanser. However, small amounts of orally administered sulfonamides have been reported to be excreted in human milk. In view of this and because many drugs are excreted in human milk, caution should be exercised when Sodium Sulfacetamide 10% and Sulfur 2% Cleanser is administered to a nursing woman.

Pediatric Use: Safety and effectiveness in children under the age of 12 has not been established.

Manufactured for:Noble Pharmaceuticals LLCCooper City, FL 33024 USA1/17

Description

DESCRIPTION: Each gram of Sodium Sulfacetamide and Sulfur (sodium sulfacetamide 10% w/w and sulfur 2% w/w) contains 100 mg of sodium sulfacetamide and 20 mg of colloidal sulfur in a vehicle consisting of:aloe vera leaf, butylated hydroxytoluene, camellia oleifera leaf, cetyl alcohol, disodium oleamido monoethanolamine sulfosuccinate, edetate disodium, fragrance, glycerin, glyceryl monostearate,
magnesium aluminum silicate, methylparaben, PEG-100 stearate, propylparaben, water, sodium cocoyl isethionate, sodium methyl cocoyl taurate, sodium thiosulfate, stearyl alcohol, xanthan gum.
Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Sodium sulfacetamide is C8H9N2NaO3S·H2O with molecular weight of 254.24. Chemically, sodium sulfacetamide is N-[(4-aminophenyl)sulfonyl] acetamide, monosodium salt, monohydrate. The structural formula is:

Clinical Pharmacology

CLINICAL PHARMACOLOGY: 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.

Indications & Usage

INDICATIONS: Sodium Sulfacetamide 10% and Sulfur 2% Cleanser is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

Contraindications

CONTRAINDICATIONS: Sodium Sulfacetamide 10% and Sulfur 2% Cleanser is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. Sodium Sulfacetamide 10% and Sulfur 2% Cleanser is not to be used by patients with kidney disease.

Warnings

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. KEEP OUT OF REACH OF CHILDREN.

Precautions

PRECAUTIONS: FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.

Adverse Reactions

ADVERSE REACTIONS: Although rare, sodium sulfacetamide may cause local irritation. Call your doctor for medical advice about side effects. To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Dosage & Administration

DOSAGE AND ADMINISTRATION: Wash affected areas with Sodium Sulfacetamide 10% and Sulfur 2% Cleanser one to two times daily, or as directed by your physician. Avoid contact with eyes or mucous membranes. Wet skin and liberally apply to areas to be cleansed, massage gently into skin for 10 to 20 seconds, working into a full lather, rinse thoroughly and pat dry. If drying occurs, it may be controlled by rinsing cleanser off sooner or using cleanser less often.

How Supplied

HOW SUPPLIED: Sodium Sulfacetamide 10% and Sulfur 2% Cleanser is supplied in an 8 oz. (227 g) bottle, NDC 70156-108-08. Store at 20°C to 25°C (67°F to 77°F); excursions permitted to between 15°C to 30°C (59°F to 86°F). See USP Controlled Room Temperature. Note: Protect from freezing and excessive heat. The product may tend to darken slightly on storage. Slight discoloration does not impair the efficacy or safety of the product. Keep tube or packet tightly closed.
Occasionally, a slight yellowish discoloration may occur when an excessive amount of the product is used and comes in contact with white fabrics. This discoloration, however, presents no problem, as it is readily removed by ordinary laundering without bleaches.

* Please review the disclaimer below.