Sodium Sulfacetamide

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Sodium Sulfacetamide Recall

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Side Effects & Adverse Reactions

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.

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Legal Issues

There is currently no legal information available for this drug.

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FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

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Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

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FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

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Uses

This product is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

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History

There is currently no drug history available for this drug.

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Other Information

Each pad is coated with a cleanser-based formulation. Each gram of solution contains 100 mg of sodium sulfacetamide and 40 mg of colloidal sulfur in a vehicle consisting of: benzyl alcohol, cetyl alcohol, fragrance, glyceryl stearate (and) PEG-100 stearate, phenoxyethanol, propylene glycol, purified water, sodium aluminum silicate, sodium lauryl sulfate, sodium magnesium sulfate, sodium thiosulfate, steryl alcohol and xanthan gum. Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Sodium sulfacetamide is C 8H 9N 2NaO 3S·H 2O 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.

Sources

Sodium Sulfacetamide Manufacturers

Biocomp Pharma, Inc.

Sodium Sulfacetamide | Biocomp Pharma, Inc.

Wash affected areas with this product once or twice daily or as directed by a physician. Moisten skin and cleansing pad with water. Work pad into full lather and massage gently into skin for 10 to 20 seconds, rinse thoroughly and pat dry. Discard pad in refuse container. If drying occurs, it may be controlled by rinsing affected area sooner or using product less frequently.

No Recall
Exact-rx, Inc.

Sodium Sulfacetamide | Exact-rx, Inc.

DOSAGE AND ADMINISTRATION: Cutaneous Bacterial Infection - Gently apply 10% Sodium Sulfacetamide Medicated Pads to the affected areas 1 to 2 times daily or as directed by a physician until the infection has cleared.

Seborrheic dermatitis - Gently apply 10% Sodium Sulfacetamide Medicated Pads to the skin or scalp 1 to 2 times daily or as directed by a physician.

Dispense in accordance with applicable state law. This product has not been approved by the FDA, is not listed in the Orange Book, and has not been approved or rated for therapeutic equivalence with any other product.

No Recall
Exact-rx, Inc.

Sodium Sulfacetamide | Exact-rx, Inc.

DOSAGE AND ADMINISTRATION: Seborrheic dermatitis including seborrhea sicca - Sodium Sulfacetamide 10% Wash: 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 10-20 seconds. 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 reinitiated as at the beginning of treatment.

Secondary cutaneous bacterial infections - Wet skin and liberally apply to areas to be cleansed, massage gently into skin for 10-20 seconds working into a full lather, rinse thoroughly and pat dry. Rinsing with plain water will remove any excess medication. Repeat application as described for eight to ten days. If skin dryness occurs it may be controlled by rinsing cleanser off sooner or using less often.

No Recall
Exact-rx, Inc.

Sodium Sulfacetamide | Exact-rx, Inc.

DOSAGE AND ADMINISTRATION: Wash affected areas once or twice daily, 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 10–20 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 less often.

No Recall
Exact-rx, Inc.

Sodium Sulfacetamide | Exact-rx, Inc.

10% Sodium Sulfacetamide 5% Sulfur Aqueous Gel (in a Urea vehicle): Cleanse affected areas. Apply a thin film into affected areas 1 to 3 times daily, or as directed by a physician.

No Recall
Acella Pharmaceuticals, Llc

Sodium Sulfacetamide | Acella Pharmaceuticals, Llc

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.

No Recall
Austin Pharmaceuticals, Llc

Sodium Sulfacetamide | Austin Pharmaceuticals, Llc

Cleanse affected areas. Apply a thin layer to the affected areas with light massaging, 1 to 3 times daily, or as directed by a physician.

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Austin Pharmaceuticals, Llc

Sodium Sulfacetamide | Austin Pharmaceuticals, Llc

Shake well before using. Apply a thin layer to the affected areas with light massaging, 1 to 3 times daily, or as directed by a physician.

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Austin Pharmaceuticals, Llc

Sodium Sulfacetamide | Austin Pharmaceuticals, Llc

Cleanse affected areas before application. Apply a thin layer to the affected areas with light massaging, 1 to 3 times daily, or as directed by a physician.

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Austin Pharmaceuticals, Llc

Sodium Sulfacetamide | Austin Pharmaceuticals, Llc

Shake well before using. Apply a thin layer to the affected areas with light massaging, 1 to 3 times daily, or as directed by a physician.

No Recall
Austin Pharmaceuticals, Llc

Sodium Sulfacetamide | Austin Pharmaceuticals, Llc

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 for 8 to 10 days. lf 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 reinitiated as at the beginning of treatment.

Secondary cutaneous bacterial infections – 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 for 8 to 10 days. If skin dryness occurs it may be controlled by rinsing cleanser off sooner or using less often.

No Recall
Trinity Pharmaceuticals, Llc

Sodium Sulfacetamide | Trinity Pharmaceuticals, Llc

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. If 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.

No Recall
Biocomp Pharma, Inc.

Sodium Sulfacetamide | Biocomp Pharma, Inc.

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.

No Recall
Biocomp Pharma, Inc.

Sodium Sulfacetamide | Biocomp Pharma, Inc.

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.

No Recall
Biocomp Pharma, Inc.

Sodium Sulfacetamide | Biocomp Pharma, Inc.

Cleanse affected areas. Apply a thin layer to the affected areas with light massaging, 1 to 3 times daily or as directed by a physician.

No Recall
Biocomp Pharma, Inc.

Sodium Sulfacetamide | Biocomp Pharma, Inc.

Cleanse affected areas. Apply a thin layer to the affected areas with light massaging, 1 to 3 times daily or as directed by a physician.

No Recall
Biocomp Pharma, Inc.

Sodium Sulfacetamide | Biocomp Pharma, Inc.

Wash affected areas once or twice daily, or as directed by your physician. 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 skin dryness occurs, it may be controlled by rinsing product off sooner or using less frequently.

No Recall
Biocomp Pharma, Inc.

Sodium Sulfacetamide | Biocomp Pharma, Inc.

Cleanse affected areas. Apply a thin layer to the affected areas with light massaging, 1 to 3 times daily or as directed by a physician.

No Recall
Prasco Laboratories

Sodium Sulfacetamide | Prasco Laboratories

Apply a thin film to affected areas twice daily.

No Recall
Biocomp Pharma, Inc.

Sodium Sulfacetamide | Biocomp Pharma, Inc.

Cleanse affected areas. Apply a thin layer to the affected areas with light massaging, 1 to 3 times daily or as directed by a physician.

No Recall
Acella Pharmaceuticals, Llc

Sodium Sulfacetamide | Acella Pharmaceuticals, Llc

DOSAGE AND ADMINISTRATION: Cleanse skin thoroughly before application. Apply a thin layer to affected areas 1-3 times daily or as directed by a physician. To minimize potential dryness, start with one application daily, then gradually increase to 2-3 times daily as needed or as directed by a physician.

No Recall