NDC 69367-245 Sodium Sulfacetamide And Sulfur

Sodium Sulfacetamide And Sulfur

NDC Product Code 69367-245

NDC CODE: 69367-245

Proprietary Name: Sodium Sulfacetamide And 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: Sodium Sulfacetamide 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

  • 69367 - Westminster Pharmaceuticals, Llc

NDC 69367-245-16

Package Description: 473 mL in 1 BOTTLE

Price per Unit: $0.09642 per ML

NDC Product Information

Sodium Sulfacetamide And Sulfur with NDC 69367-245 is a a human prescription drug product labeled by Westminster Pharmaceuticals, Llc. The generic name of Sodium Sulfacetamide And Sulfur is sodium sulfacetamide and sulfur. The product's dosage form is suspension and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1010234.

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.

Sodium Sulfacetamide And 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.


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: Westminster Pharmaceuticals, Llc
Labeler Code: 69367
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: 06-18-2021 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.

Sodium Sulfacetamide And 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

In a vehicle containing Green Tea and AloeRx OnlyFOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.All prescription substitutions 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 s ubjected to FDA therapeutic equivalency or other equivalency testing. No representation is made as to generic status or bioequivalency. Each person recommending a prescription substitution using this product shall make such recommendations based on each such person's professional opinion and knowledge, upon evaluating the active ingredients, excipients, inactive ingredients and chemical formulation information provided herein.

Manufactured for:Westminster Pharmaceuticals LLC.Nashville TN, 37217Rev. 04/21

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 of Sodium Sulfacetamide 8% and Sulfur 4% Topical Suspension contains 80 mg of Sodium Sulfacetamide and 40 mg of Sulfur in a formulation containing 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

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 not known, but it has been reported that it inhibits the growth of Propionibacterium acnes and the formation of free fatty acids.

Indications

Sodium Sulfacetamide 8% and Sulfur 4% Topical Suspension is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

Contraindications

Sodium Sulfacetamide 8% and Sulfur 4% Topical Suspension is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. Sodium Sulfacetamide 8% and Sulfur 4% Topical Suspension is not to be used by patients with kidney disease.

Warnings

Although rare, sensitivity to sodium sulfacetaminde 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.FOR EXTERNAL USE ONLY. Keep away from eyes. Keep out of reach of children. Keep container tightly closed.

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 possibilty.

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.

Category C

Animal reproduction studies have not been conducted with Sodium Sulfacetamide 8% and Sulfur 4% Topical Suspension. It is not known whether Sodium Sulfacetamide 8% and Sulfur 4% Topical Suspension can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium Sulfacetamide 8% and Sulfur 4% Topical Suspension 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 Sodium Sulfacetamide 8% and Sulfur 4% Topical Suspension. 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 Sodium Sulfacetamide 8% and Sulfur 4% Topical Suspension 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.Call your doctor for medical advice about side effects. To report a serious adverse event, please contact Westminster Pharmaceuticals at 1-844-221-7294.

Dosage And Administration

Apply Sodium Sulfacetamide 8% and Sulfur 4% Topical Suspension 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 Sodium Sulfacetamide 8% and Sulfur 4% Topical Suspension sooner or using less often.

How Supplied

Sodium Sulfacetamide 8% and Sulfur 4% Topical Suspension is available in 16 fl oz (473 mL) bottles, NDC 69367-245-16

Storage And Handling

Store at controlled room temperature, 15° - 30°C (59° - 86°F). Protect from freezing.

* Please review the disclaimer below.