Label: SULFACETAMIDE SODIUM suspension
Contains inactivated NDC Code(s)
NDC Code(s): 54868-6225-0
- Packager: Physicians Total Care, Inc.
- This is a repackaged label.
- Source NDC Code(s): 0168-0382-04
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated September 1, 2009
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- SPL UNCLASSIFIED SECTION
Each mL of Sulfacetamide Sodium Topical Suspension USP, 10% contains 100 mg of sulfacetamide sodium in a vehicle consisting of purified water, propylene glycol, lauramide DEA (and) diethanolamine, polyethylene glycol 400 monolaurate, hydroxyethyl cellulose, sodium chloride, sodium metabisulfite, methylparaben, xanthan gum, EDTA and simethicone. Sulfacetamide sodium is a sulfonamide with antibacterial activity. Chemically sulfacetamide sodium is N' -[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:
The most widely accepted mechanism of action of sulfonamides is the Woods-Fildes theory, based on sulfonamides acting as a competitive inhibitor of para-aminobenzoic acid (PABA) utilization, an essential component for bacterial growth. While absorption through intact skin in humans has not been determined, in vitro studies with human cadaver skin indicated a percutaneous absorption of about 4%. Sulfacetamide sodium is readily absorbed from the gastrointestinal tract when taken orally and excreted in the urine largely unchanged. The biological half-life has been reported to be between 7 to 13 hours.
- INDICATIONS AND USAGE
Sulfacetamide Sodium Topical Suspension USP, 10% is contraindicated for use by patients having a known hypersensitivity to sulfonamides or any other component of this preparation (see WARNINGS section).
Fatalities have occurred, although rarely, due to severe reactions to sulfonamides including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, and other blood dyscrasias. Hypersensitivity reactions may occur when a sulfonamide is readministered, irrespective of the route of administration. Sensitivity reactions have been reported in individuals with no prior history of sulfonamide hypersensitivity. At the first sign of hypersensitivity, skin rash or other reactions, discontinue use of this preparation (see ADVERSE REACTIONS section).
Sulfacetamide Sodium Topical Suspension USP, 10% contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than non-asthmatic people (see CONTRAINDICATIONS section).
General: For external use only. Keep away from eyes. 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. Hypersensitivity reactions may occur when a sulfonamide is readministered irrespective of the route of administration, and cross-sensitivity between different sulfonamides may occur. Sulfacetamide sodium can cause reddening and scaling of the skin. Particular caution should be employed if areas of involved skin to be treated are denuded or abraded.
Keep out of reach of children.
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 Sulfacetamide Sodium Topical Suspension USP, 10%. It is also not known whether Sulfacetamide Sodium Topical Suspension USP, 10% can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sulfacetamide Sodium Topical Suspension USP, 10% should be given to a pregnant woman only if clearly needed.
Kernicterus may occur in the newborn as a result of treatment of a pregnant woman at term with orally administered sulfonamide. There are no adequate and well controlled studies of Sulfacetamide Sodium Topical Suspension USP, 10% in pregnant women, and it is not known whether topically applied sulfonamides can cause fetal harm when administered to a pregnant woman.
Nursing Mothers: It is not known whether sulfacetamide sodium is excreted in the human milk following topical use of Sulfacetamide Sodium Topical Suspension USP, 10%. Systemically administered sulfonamides are capable of producing kernicterus in the infants of lactating women. Small amounts of orally administered sulfonamides have been reported to be eliminated in human milk. Because many drugs are excreted in human milk, caution should be exercised in prescribing for nursing mothers.
In controlled clinical trials for the management of acne vulgaris, the occurrence of adverse reactions associated with the use of Sulfacetamide Sodium Topical Suspension USP, 10% was infrequent and restricted to local events. The total incidence of adverse reactions reported in these studies was less than 2%. Only one of 105 patients treated with Sulfacetamide Sodium Topical Suspension USP, 10% had local adverse reactions of erythema, itching and edema. It has been reported that sulfacetamide sodium may cause local irritation, stinging and burning. While the irritation may be transient, occasionally, the use of the medication has to be discontinued.
- DOSAGE AND ADMINISTRATION
Sulfacetamide Sodium Topical Suspension USP, 10%, is supplied in
118 mL bottles NDC 54868-6225-0
Store at controlled room temperature 20°-25°C (68°-77°F) [see USP].
Shake well before using. Keep tightly closed.
E. FOUGERA & CO.
A division of Nycomed US Inc.
MELVILLE, NEW YORK 11747
Relabeling of "Additional" barcode label by:
Physicians Total Care, Inc.
Tulsa, OK 74146
PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 118 mL (4 fl oz)
SUSPENSION USP, 10%
USUAL DOSAGE: Shake well before using. Apply a thin film to the affected areas twice daily. See package insert for full prescribing information.
WARNING: Keep away from eyes. For external use only. Keep out of reach of children.
Store at Controlled Room Temperature 20°-25°C (68°-77°F) [see USP]. Keep tightly closed.
Each mL of Sulfacetamide Sodium Topical Suspension USP, 10% contains 100 mg of sulfacetamide sodium in a vehicle consisting of purified water, propylene glycol, lauramide DEA (and) diethanolamine, polyethylene glycol 400 monolaurate, hydroxyethyl cellulose, sodium chloride, sodium metabisulfite, methylparaben, xanthan gum, EDTA and simethicone.
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
sulfacetamide sodium suspension
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-6225(NDC:0168-0382-04) Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SULFACETAMIDE SODIUM (UNII: 4NRT660KJQ) (SULFACETAMIDE - UNII:4965G3J0F5) SULFACETAMIDE SODIUM 100 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM METABISULFITE (UNII: 4VON5FNS3C) EDETATE DISODIUM (UNII: 7FLD91C86K) XANTHAN GUM (UNII: TTV12P4NEE) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) METHYLPARABEN (UNII: A2I8C7HI9T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54868-6225-0 1 in 1 CARTON 1 118 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077015 01/19/2011 Labeler - Physicians Total Care, Inc. (194123980) Establishment Name Address ID/FEI Business Operations Physicians Total Care, Inc. 194123980 relabel