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Sodium Sulfacetamide 9% and Sulfur 4.5% Cleanser

RxNorm 1115894· SULFACETAMIDE SODIUM, SULFUR· TOPICAL

Bryant Ranch Prepack

Indications and usage

INDICATIONS SODIUM SULFACETAMIDE 9% - SULFUR 4.5% CLEANSER is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

Dosage and administration

DOSAGE AND ADMINISTRATION Wash affected area 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. See label booklet for Full Prescribing Information.

Warnings

WARNINGS Although it is 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. NOT FOR INTRAVAGINAL OR OPHTHALMIC USE. (KEEP AWAY FROM EYES). KEEP OUT OF REACH OF CHILDREN. In case of accidental ingestion contact a poison control center immediately. Keepcontainer tightly closed.

Contraindications

CONTRAINDICATIONS: SODIUM SULFACETAMIDE 9% - SULFUR 4.5% CLEANSER is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. SODIUM SULFACETAMIDE 9% - SULFUR 4.5% CLEANSER is not to be used by patients with kidney disease.

Adverse events

Most frequently reported events (FDA FAERS). Report frequency does not imply causation.

  • pain9
  • drug ineffective7
  • nausea7
  • anxiety5
  • erythema5
  • fall5
  • hypersensitivity5
  • rash5
  • rosacea5
  • dry skin4
  • dyspnoea4
  • eye irritation4
  • malaise4
  • product substitution issue4
  • pulmonary embolism4
  • urticaria4

Adverse reactions (label)

Adverse Reaction Although rare, sodium sulfacetamide may cause local irritation. Call your doctor for medical advice about side effects. To report a serious adverse event or obtain product information, call 1-877-250-3427.

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