RVP

Drug Catalog - Product Detail

SILVER SULFADIAZINE (SSD 1% CREAM - JAR) CRM 0.01 400GM

NDC Mfr Size Str Form
67877-0124-40 ASCEND LABORATORIES 400 1% CREAM
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Description
DESCRIPTION Silver sulfadiazine cream, USP 1% is a soft, white, water dispersible cream containing the antimicrobial agent silver sulfadiazine in micronized form for topical application. Each gram of silver sulfadiazine cream contains 10mg of micronized silver sulfadiazine. This active agent has the following structural formula: Silver sulfadiazine cream contains 1% w/w silver sulfadiazine. The vehicle in which the active ingredient is dispersed consists of water, stearyl alcohol, white petrolatum, polyoxyl 40 stearate, propylene glycol, isopropyl myristate, and sorbitan monooleate with 0.3% methylparaben as a preservative. Structural Formula
How Supplied
HOW SUPPLIED Silver sulfadiazine cream, USP 1% - white to off-white cream NDC Number Size 67877-124-20 20g tube 67877-124-25 25g tube 67877-124-05 50g tube 67877-124-85 85g tube 67877-124-50 50g jar 67877-124-40 400g jar 67877-124-10 1000g jar Store at room temperature. 15°-30°C (59°-86°F). Manufactured for: Ascend Laboratories, LLC Parsippany, NJ 07054 Manufactured by: Crown Laboratories, Inc. Johnson City, TN 37604 Product information: 1-877-272-7901 Revised: SEPT 2016 P1840.03
Indications & Usage
INDICATIONS AND USAGE Silver sulfadiazine cream, USP 1% is a topical antimicrobial drug indicated as an adjunct for the prevention and treatment of wound sepsis in patients with second and third degree burns.
Dosage and Administration
DOSAGE AND ADMINISTRATION Prompt institution of appropriate regimens for care of the burned patient is of prime importance and includes the control of shock and pain. The burn wounds are then cleansed and debrided; silver sulfadiazine cream, USP 1% is then applied under sterile conditions. The burn areas should be covered with silver sulfadiazine cream, USP 1% at all times. The cream should be applied once to twice daily to a thickness of approximately one sixteenth of an inch. Whenever necessary, the cream should be reapplied to any areas from which it has been removed by patient activity. Administration may be accomplished in minimal time because dressings are not required. However, if individual patient requirements make dressings necessary, they may be used. Reapply immediately after hydrotherapy. Treatment with silver sulfadiazine cream, USP 1% should be continued until satisfactory healing has occurred or until the burn site is ready for grafting. The drug should not be withdrawn from the therapeutic regimen while there remains the possibility of infection except if a significant adverse reaction occurs.