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NDC 63629-2032-01 Sodium Sulfacetamide 9 Sulfur 4.5 Wash 9; 4.5 mg/g; mg/g Details
Sodium Sulfacetamide 9 Sulfur 4.5 Wash 9; 4.5 mg/g; mg/g
Sodium Sulfacetamide 9 Sulfur 4.5 Wash is a TOPICAL RINSE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is SULFACETAMIDE SODIUM; SULFUR.
Product Information
| NDC | 63629-2032 |
|---|---|
| Product ID | 63629-2032_4b17e2e1-a94f-47bd-b551-769279da8de2 |
| Associated GPIs | 90059903200915 |
| GCN Sequence Number | 067591 |
| GCN Sequence Number Description | sulfacetamide sodium/sulfur CLEANSER 9 %-4.5 % TOPICAL |
| HIC3 | Q5S |
| HIC3 Description | TOPICAL SULFONAMIDES |
| GCN | 30172 |
| HICL Sequence Number | 003344 |
| HICL Sequence Number Description | SULFACETAMIDE SODIUM/SULFUR |
| Brand/Generic | Generic |
| Proprietary Name | Sodium Sulfacetamide 9 Sulfur 4.5 Wash |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Sulfacetamide Sodium and Sulfur |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | RINSE |
| Route | TOPICAL |
| Active Ingredient Strength | 9; 4.5 |
| Active Ingredient Units | mg/g; mg/g |
| Substance Name | SULFACETAMIDE SODIUM; SULFUR |
| Labeler Name | Bryant Ranch Prepack |
| Pharmaceutical Class | Sulfonamide Antibacterial [EPC], Sulfonamides [CS] |
| DEA Schedule | n/a |
| Marketing Category | UNAPPROVED DRUG OTHER |
| Application Number | n/a |
| Listing Certified Through | 2023-12-31 |
Package
Package Images
NDC 63629-2032-01 (63629203201)
| NDC Package Code | 63629-2032-1 |
|---|---|
| Billing NDC | 63629203201 |
| Package | 1 BOTTLE in 1 CARTON (63629-2032-1) / 454 g in 1 BOTTLE |
| Marketing Start Date | 2012-12-10 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 86a58b0e-d8f5-405b-aecf-862b8a3ccf57 Details
DESCRIPTION
Sodium Sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Chemically, Sodium Sulfacetamide is N-[(4-aminophenyl)sulfony]-acetamide, monosodium salt, monohydrate. The structural formula is:
Each mL of Sodium Sulfacetamide 9% & Sulfur 4.5% Wash contains 90 mg of sodium sulfacetamide and 45 mg of sulfur in a formulation consisting of: aloe vera, fragrance, butylated hydroxytoluene, cetyl alcohol, disodium EDTA, disodium oleamido MEA sulfosuccinate, glyceryl stearate (and) PEG-100 stearate, green tea extract, magnesium aluminum silicate, methylparaben, propylparaben, purified water, sodium cocoyl isethionate, sodium methyl cocoyl tau rate, sodium thiosulfate, stearyl alcohol and xanthan gum.
CLINICAL PHARMACOLOGY
The most widely accepted mechanism of action of sulfonamides in 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 AND USAGE
CONTRAINDICATIONS
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.
FOR EXTERNAL USE ONLY. Keep away from eyes. Keep out of reach of children. Keep container tightly closed.
PRECAUTIONS
General
If irritation develops, use of this product should be discontinued and appropriate therapy instituted. Patients should be very 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.
Information for Patients
Avoid contact with eyes, eyelids, lips and mucuos membranes. If accidental contact occures, 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.
Pregnancy
Category C
Animal reproduction studies have not been conducted with Sodium Sulfacetamide 9% & Sulfur 4.5% Wash. It is also not known whether Sodium Sulfacetamide 9% & Sulfur 4.5% Wash can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium Sulfacetamide 9% & Sulfur 4.5% Wash 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 9% & Sulfur 4.5% Wash. 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 9% & Sulfur 4.5% Wash is administered to a nursing woman.
DOSAGE AND ADMINISTRATION
Apply Sodium Sulfacetamide 9% & Sulfur 4.5% Wash 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 lather. Rinse thoroughly and pat dry. If drying occurs, it may be controlled by rinsing off Sodium Sulfacetamide 9% & Sulfur 4.5% Wash sooner or using less often.
HOW SUPPLIED
Sodium Sulfacetamide 9% & Sulfur 4.5% Wash is available in in a 16 oz (454 g) bottle, NDC 63629-2032-1.
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. Protect from freezing.
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
| SODIUM SULFACETAMIDE 9 SULFUR 4.5 WASH
sulfacetamide sodium and sulfur rinse |
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| Labeler - Bryant Ranch Prepack (171714327) |
| Registrant - Bryant Ranch Prepack (171714327) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Bryant Ranch Prepack | 171714327 | REPACK(63629-2032) , RELABEL(63629-2032) | |