Sodium Sulfacetamide Wash

Name: Sodium Sulfacetamide Wash

Indications

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

Overdosage

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 or your doctor.

How supplied

This product is supplied in the following size(s):
12 fl. oz. (355 mL) bottles, NDC 44523-606-12

16 fl. oz. (473 mL) bottles, NDC 44523-606-16

To report a serious adverse event or obtain product information, call 1-866-762-2365.

Manufactured for:

BIOCOMP PHARMA ®, INC.
San Antonio, TX 78230 1355

SODIUM SULFACETAMIDE 
sodium sulfacetamide liquid
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:44523-606
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 mL
Inactive Ingredients
Ingredient Name Strength
METHYLPARABEN  
CAPRYLIC/CAPRIC ACID  
SODIUM CHLORIDE  
PEG-150 PENTAERYTHRITYL TETRASTEARATE  
PEG-60 ALMOND GLYCERIDES  
PROPYLENE GLYCOL  
PROPYLPARABEN  
WATER  
SODIUM LAURETH SULFATE  
COCO DIETHANOLAMIDE  
COCAMIDOPROPYL BETAINE  
GLYCOL STEARATE  
CITRIC ACID MONOHYDRATE  
EDETATE SODIUM  
Product Characteristics
Color yellow (slight yellow) Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description
1 NDC:44523-606-16 473 mL in 1 BOTTLE, PLASTIC
2 NDC:44523-606-12 355 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 01/07/2013
Labeler - BioComp Pharma, Inc. (829249718)
Revised: 05/2017   BioComp Pharma, Inc.
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