Sodium Sulfacetamide 10% Wash, Rx Only

DESCRIPTION:

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displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

Sodium sulfacetamide is C
₈H
₉N
₂NaO
₃S·H
₂O with molecular weight of 254.24. Chemically, it is Acetamide N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is: Each gram of Sodium Sulfacetamide 10% Wash contains 100 mg of Sodium Sulfacetamide, USP in a formulation containing cocamidopropyl betaine, disodium EDTA,PEG-150 pentaerythrityl tetrastearate and PEG 6 caprylic/capric glycerides, glyceryl monostearate, methyl paraben, PEG-60 almond triglyceride, polysorbate 60,
purified water, sodium lauryl sulfate and sodium thiosulfate. 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:

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displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1

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 Sodium Sulfacetamide 10% Wash 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 not known. Organisms which show susceptibility to sodium sulfacetamide are:
Streptococci, Staphylococci, E. coli, Klebsiella pneumonia, Pseudomonas pyocyanea, Salmonella species, Proteus vulgaris, Nocardia and Actinomyces .

INDICATIONS:

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displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9

Sodium Sulfacetamide 10% Wash is intended for topical application in the following scaling dermatoses: seborrheic dermatitis and seborrhea sicca (dandruff). It is also indicated for the treatment of secondary bacterial infections of the skin due to organisms susceptible to sulfonamides.

CONTRAINDICATIONS:

id: 620b7b44-3d64-608a-e053-2991aa0a8f3c
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

Sodium Sulfacetamide 10% Wash is contraindicated for use by patients having known hypersensitivity to sulfonamides or any other component of this product.

WARNINGS:

id: 620b7b44-3d65-608a-e053-2991aa0a8f3c
displayName: WARNINGS SECTION
FDA Article Code: 34071-1

Sulfonamides are known to cause Stevens-Johnson syndrome in hypersensitivie 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:

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displayName: PRECAUTIONS SECTION
FDA Article Code: 42232-9

For external use only.

Drug Interactions:

id: 620b7b44-3d69-608a-e053-2991aa0a8f3c
displayName: DRUG INTERACTIONS SECTION
FDA Article Code: 34073-7

Sodium Sulfacetamide 10% Wash is incompatible with silver preparations.

PREGNANCY:

id: 620b7b44-3d6b-608a-e053-2991aa0a8f3c
displayName: PREGNANCY SECTION
FDA Article Code: 42228-7

Category C. Animal reproduction studies have not been conducted with Sodium Sulfacetamide 10% Wash. It is not known whether Sodium Sulfacetamide 10% Wash can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium Sulfacetamide 10% Wash should be given to a pregnant woman only if clearly needed or when potential benefits outweigh potential hazards to the fetus.

NURSING MOTHERS:

id: 620b7b44-3d6c-608a-e053-2991aa0a8f3c
displayName: NURSING MOTHERS SECTION
FDA Article Code: 34080-2

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be when Sodium Sulfacetamide 10% Wash is administered to a nursing woman.

PEDIATRIC USE:

id: 620b7b44-3d6d-608a-e053-2991aa0a8f3c
displayName: PEDIATRIC USE SECTION
FDA Article Code: 34081-0

Safety and effectiveness in children under the age of 12 have not been established.

ADVERSE REACTIONS:

id: 620b7b44-3d6e-608a-e053-2991aa0a8f3c
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4

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:

id: 620b7b44-3d6f-608a-e053-2991aa0a8f3c
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5

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.

DOSAGE AND ADMINISTRATION:

id: 620b7b44-3d70-608a-e053-2991aa0a8f3c
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7

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 and pat dry. Rinsing with plain water will remove any excess medication. Repeat application as described for eight to ten days. If skin dryness occurs it may be controlled by rinsing cleanser off sooner or using less frequently. Regular shampooing following Sodium Sulfacetamide 10% Wash 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 Sodium Sulfacetamide 10% Wash should be reinstated as at the beginning of treatment.
Secondary Cutaneuos Bacterial Infections
– Wet skin and liberally apply to areas to be cleansed, massage gently
into skin working into a full lather, rinse thoroughly and pat dry. Rinsing with plain water will remove any excess medication. Repeat application as described for eight to ten days. if skin dryness occurs it may be controlled by rinsing cleanser off sooner or using less often.

HOW SUPPLIED:

id: 620b7b44-3d71-608a-e053-2991aa0a8f3c
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Sodium Sulfacetamide 10% Wash is available in 16 fluid ounce bottles, NDC 42192-129-16.

PACKAGE LABEL – 10% Wash

id: 620b7b44-3d74-608a-e053-2991aa0a8f3c
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

NDC 42192-129-16 Sodium Sulfacetamide

10%
Wash
Rx Only For External Use Only 16 fl. oz. (480 mL) Acella

PHARMACEUTICALS, LLC