NDC 71399-0486 Sodium Sulfacetamide 9.8% And Sulfur 4.8% Cleanser

Sulfacetamide Sodium, Sulfur

NDC Product Code 71399-0486

NDC CODE: 71399-0486

Proprietary Name: Sodium Sulfacetamide 9.8% And Sulfur 4.8% Cleanser 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, 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used to treat bacterial eye infections (such as conjunctivitis). It belongs to a class of drugs known as sulfa antibiotics. Sulfacetamide works by stopping the growth of bacteria. This medication treats only bacterial eye infections. It will not work for other types of eye infections. Unnecessary use or misuse of any antibiotic can lead to its decreased effectiveness.

NDC Code Structure

  • 71399 - Akron Pharma Inc.
    • 71399-0486 - Sodium Sulfacetamide 9.8% And Sulfur 4.8% Cleanser

NDC 71399-0486-1

Package Description: 285 g in 1 BOTTLE, PLASTIC

NDC Product Information

Sodium Sulfacetamide 9.8% And Sulfur 4.8% Cleanser with NDC 71399-0486 is a a human prescription drug product labeled by Akron Pharma Inc.. The generic name of Sodium Sulfacetamide 9.8% And Sulfur 4.8% Cleanser is sulfacetamide sodium, sulfur. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Akron Pharma Inc.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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 9.8% And Sulfur 4.8% Cleanser 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 9.8 mg/g
  • SULFUR 4.8 mg/g

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)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • PEG-40 STEARATE (UNII: ECU18C66Q7)
  • PEG-60 ALMOND GLYCERIDES (UNII: 4Y0E651N0F)
  • PEG-6 CAPRYLIC/CAPRIC GLYCERIDES (UNII: GO50W2HWO8)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • 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.
  • 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: Akron Pharma Inc.
Labeler Code: 71399
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: 11-09-2020 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: 12-31-2021 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 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. Values = ‘Y’ or ‘N’.

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Sodium Sulfacetamide 9.8% And Sulfur 4.8% Cleanser Product Label Images

Sodium Sulfacetamide 9.8% And Sulfur 4.8% Cleanser 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 Only

Description

Each gram of Sodium Sulfacetamide 9.8% - Sulfur 4.8% Cleanser contains 98 mg of Sodium Sulfacetamide and 48 mg of Sulfur in a formulation containing aloe vera gel,butylated hydroxytoluene, cetyl alcohol, disodium edetate, glyceryl monostearate, magnesium aluminum silicate, methylparaben, PEG-40 stearate, PEG -6 caprylic/capric glyceride,PEG-60 almond glyceride, propylparaben, propylene glycol,purified water, sodium thiosulfate, sodium lauryl sulfate, stearyl alcohol, and xanthan gumSodium 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:

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

SODIUM SULFACETAMIDE 9.8% - SULFUR 4.8% CLEANSER is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

Contraindications:

SODIUM SULFACETAMIDE 9.8% - SULFUR 4.8% CLEANSER is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. SODIUM SULFACETAMIDE 9.8% - SULFUR 4.8% CLEANSER 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. KEEP OUT OF REACH OF CHILDREN.

Precautions

FOR 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 9.8% - SULFUR 4.8% CLEANSER. It is also not known whether SODIUM SULFACETAMIDE 9.8% - SULFUR 4.8% CLEANSER can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. SODIUM SULFACETAMIDE 9.8% - SULFUR 4.8% 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 topicaI use of SODIUM SULFACETAMIDE 9.8% - SULFUR 4.8% 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 9.8% - SULFUR 4.8% CLEANSER is administered to a nursing woman.Pediatric Use: Safety and effectiveness in children under the age of 12 has not been established.

Adverse Reactions

Although rare, sodium sulfacetamide may cause local irritation. Call your doctor for medical advice about side effects.

Dosage And Administration

Wash affected areas with SODIUM SULFACETAMIDE 9.8% - SULFUR 4.8% CLEANSER 1 to 2 times daily or as directed by a 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

SODIUM SULFACETAMIDE 9.8% - SULFUR 4.8% CLEANSER is supplied in an 10oz. (285 g) bottle, NDC 71399-0486-1

Storage

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° 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 container 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.All prescription substitutions and/or recommendations using this product shall be made subject to state and federal statutes as applicable. Please NOTE: This is not an Orange Book product and has not been subjected to FDA therapeutic 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 recommendation based on his/her professional knowledge and opinion, upon evaluating the active ingredients, inactive ingredients, excipients and chemical information provided herein.QUESTIONS?Please Call 1(877) 225-6999Manufactured for: Akron Pharma, Inc.Fairfield, NJ 07004Manufactured in U.S.A

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