Avar Cleansing Pads

Name: Avar Cleansing Pads

Clinical pharmacology

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 this product 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 unknown. Organisms that show susceptibility to sodium sulfacetamide are: Streptococci, Staphylococci, E. coli, Klebsiella pneumoniae, Pseudomonas pyocyanea, Salmonella species, Proteus vulgaris, Nocardia and Actinomyces. 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

This product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product. This product is not to be used by patients with kidney disease.

Warnings

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.

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):
30 count carton, NDC 0178-0650-30
60 count carton, NDC 0178-0650-60

To report a serious adverse event or obtain product information, call 1-800-298-1087.

Manufactured for:
MISSION PHARMACAL COMPANY
San Antonio, TX 78230 1355

Avar Cleansing Pads 
sulfacetamide sodium, sulfur cloth
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0178-0650
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SULFACETAMIDE SODIUM (SULFACETAMIDE) SULFACETAMIDE SODIUM 95 mg  in 1 g
SULFUR (SULFUR) SULFUR 50 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
BENZYL ALCOHOL  
CETYL ALCOHOL  
GLYCERYL MONOSTEARATE  
PEG-100 STEARATE  
MAGNESIUM ALUMINUM SILICATE  
PHENOXYETHANOL  
PROPYLENE GLYCOL  
WATER  
SODIUM LAURYL SULFATE  
LAPONITE  
SODIUM THIOSULFATE  
STEARYL ALCOHOL  
XANTHAN GUM  
Product Characteristics
Color yellow (light yellow) Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description
1 NDC:0178-0650-60 60 PACKET in 1 CARTON
1 NDC:0178-0650-01 4 g in 1 PACKET
2 NDC:0178-0650-30 30 PACKET in 1 CARTON
2 NDC:0178-0650-01 4 g in 1 PACKET
3 NDC:0178-0650-10 10 PACKET in 1 CARTON
3 NDC:0178-0650-01 4 g in 1 PACKET
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 09/15/2011
Labeler - Mission Pharmacal Company (008117095)
Revised: 04/2017   Mission Pharmacal Company
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