SE 10-5 SS Cream

Name: SE 10-5 SS Cream

SE 10-5 SS Cream (sodium sulfacetamide 10% and sulfur 5%)

Rx Only

Description

Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Chemically sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:

Each gram of SE 10-5 SS (sodium sulfacetamide USP 10% and sulfur USP 5%) Cream contains: Active: Sodium Sulfacetamide 10% (100 mg) and Sulfur 5% (50 mg). Inactive: Benzyl Alcohol, Emulsifying Wax, Fragrance, Hamaelis virginiana (Witch Hazel) Distillate, Kaolin, Propanediol, Purified Water, Quillaja (Quillaia) saponaria Extract, Silicon Dioxide, Sodium Hydroxide, and Sodium Thiosulfate.

Clinical pharmacology

The most widely accepted mechanism of action of sulfonamides is 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.

Contraindications

SE 10-5 SS (sodium sulfacetamide 10% and sulfur 5%) Cream is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. SE 10-5 SS (sodium sulfacetamide 10% and sulfur 5%) Cream is not to be used by patients with kidney disease.

PACKAGE LABEL- 113.4 g Tube Carton

NDC 13925-114-04        Rx Only

SE 10-5 SS CREAM

(sodium sulfacetamide 10% and sulfur 5%)

4 oz. Cream

SETON PHARMACEUTICALS

SE 10-5 SS 
sodium sulfacetamide, sulfur cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:13925-114
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SULFACETAMIDE SODIUM (SULFACETAMIDE) SULFACETAMIDE SODIUM 100 mg  in 1 g
SULFUR (SULFUR) SULFUR 50 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
BENZYL ALCOHOL  
WHITE WAX  
WITCH HAZEL  
KAOLIN  
PROPANEDIOL  
WATER  
QUILLAJA SAPONARIA BARK  
SILICON DIOXIDE  
SODIUM HYDROXIDE  
SODIUM THIOSULFATE  
Packaging
# Item Code Package Description
1 NDC:13925-114-04 1 TUBE (TUBE) in 1 CARTON
1 113.4 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 05/15/2010 01/15/2015
Labeler - Seton Pharmaceuticals (828898002)
Revised: 08/2014   Seton Pharmaceuticals

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Very bad skin irritation.
  • Very bad and rarely deadly effects have happened with sulfa (sulfonamide) drugs like this one. These effects have included liver problems, blood problems, and very bad skin reactions (Stevens-Johnson syndrome/toxic epidermal necrolysis). Call your doctor right away if you have a rash; red, swollen, blistered, or peeling skin; red or irritated eyes; sores in your mouth, throat, nose, or eyes; fever, chills, or sore throat; cough that is new or worse; feeling very tired or weak; any bruising or bleeding; or signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
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