NDC 71399-0480 Sodium Sulfacetamide

Sodium Sulfacetamide

NDC Product Code 71399-0480

NDC Code: 71399-0480

Proprietary Name: Sodium Sulfacetamide 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 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.


Code Structure
  • 71399 - Akron Pharma Inc
    • 71399-0480 - Sodium Sulfacetamide

NDC 71399-0480-2

Package Description: 360 mL in 1 BOTTLE

NDC 71399-0480-6

Package Description: 480 mL in 1 BOTTLE

NDC Product Information

Sodium Sulfacetamide with NDC 71399-0480 is a a human prescription drug product labeled by Akron Pharma Inc. The generic name of Sodium Sulfacetamide is sodium sulfacetamide. 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 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 100 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.

  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • PEG-6 CAPRYLIC/CAPRIC GLYCERIDES (UNII: GO50W2HWO8)
  • PEG-60 ALMOND GLYCERIDES (UNII: 4Y0E651N0F)
  • PEG-150 PENTAERYTHRITYL TETRASTEARATE (UNII: 8L4OOQ76AM)
  • POLYSORBATE 60 (UNII: CAL22UVI4M)
  • WATER (UNII: 059QF0KO0R)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • SODIUM THIOSULFATE (UNII: HX1032V43M)
  • 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.

* Please review the disclaimer below.

Sodium Sulfacetamide Product Label Images

Sodium Sulfacetamide 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

Description:

Each gram contains 100 mg of sodium sulfacetamide USP in a vehicle consisting of: citric acid, cocamidopropyl betaine, disodium EDTA, glyceryl monostearate, methylparaben, PEG-6 caprylic/capric glycerides, PEG-60 almond glycerides, PEG-150 pentaerythrityl tetrastearate, polysorbate 60, purified water,cetyl alcohol, glycerin,sodium lauryl sulfate, sodium thiosulfate and xanthan gum.Sodium sulfacetamide is a sulfonamide with antibacterial activity. 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:Sodium sulfacetamide is an odorless, white, crystalline powder with a bitter taste. It is freely soluble in water, sparingly soluble in alcohol, while practically insoluble in benzene, in chloroform and in ether.

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.

Indications:

This product is intended for topical application in the following scaling dermatoses: seborrheic dermatitis and seborrhea sicca (dandruff). It also is indicated for the treatment of secondary bacterial infections of the skin due to organisms susceptible to sulfonamides.

Contraindications:

This product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product. This product is not to be used by patients with kidney disease.

This product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product. This product is not to be used by patients with kidney disease.

Warnings:

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 THE REACH OF CHILDREN.

Precautions: For External Use Only. Not For Ophthalmic Use.

General: Nonsusceptible organisms, including fungi, may proliferate with the use of this preparation.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. If the use of this product produces signs of hypersensitivity or other untoward reactions, discontinue use of the preparation. Patients should be carefully observed for possible local irritation or sensitization during long-term therapy. 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. 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.Information for Patients: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 also should be discontinued promptly and the physician notified if any arthritis, fever or sores in the mouth develop. Avoid contact with eyes, lips and mucous membranes.Drug Interactions: This product is incompatible with silver preparations.Carcinogenesis, Mutagenesis and Impairment of Fertility: Long-term animal studies for carcinogenic potential have not been performed on this product to date. 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.Pregnancy:Category C. Animal reproduction studies have not been conducted with this product. It is also not known whether this product can affect reproduction capacity or cause fetal harm when administered to a pregnant woman. This product should be used by 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 human milk. Because many drugs are excreted in human milk, caution should be exercised when this product is administered to a nursing woman.Pediatric Use: Safety and effectiveness in children under the age of 12 years 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).

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 or your doctor.

Dosage And Administration:

Seborrheic dermatitis including seborrhea sicca - Wash affected areas twice daily (morning and evening) 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 working into a full lather, rinse thoroughly, pat dry and repeat after 10 to 20 seconds. Rinsing with plain water will remove any excess medication. Repeat application as described above for 8 to 10 days or as directed by your physician. lf skin dryness occurs it may be controlled by rinsing cleanser off sooner or using less frequently. Regular shampooing following the use of this product is not necessary, but the hair should be shampooed at least once a week. As the condition subsides, the interval between applications may be lengthened. Applications once or twice weekly or every other week may prevent recurrence. Should the condition recur after stopping therapy, the application of this product should be reinitiated as at the beginning of treatment.Secondary cutaneous bacterial infections - Wash affected areas twice daily (morning and evening) 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. Rinsing with plain water will remove any excess medication. Repeat application as described above for 8 to 10 days or as directed by your physician. If skin dryness occurs it may be controlled by rinsing cleanser off sooner or using less frequently.STORAGE: Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F). Brief exposure to temperatures up to 40°C (104°F) may be tolerated provided the mean kinetic temperature does not exceed 25°C (77°F); however, such exposure should be minimized.NOTICE: 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 bottle tightly closed.Occasionally, a slight discoloration of fabric 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.

How Supplied:

This product is supplied in the following size(s):12 fl. oz. (360 mL) bottles, NDC 71399-0480-216 fl. oz. (480 mL) bottles, NDC 71399-0480-6To report a serious adverse event or obtain product information, call 973-227-2000.Manufactured for:Akron Pharma Inc.Fairfield, NJ 07004

* Please review the disclaimer below.

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