Drug Catalog - Product Detail
SILVER SULFADIAZINE SSD 1% CREAM 1% CRM 50GM
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 43598-0210-50 | DR.REDDY'S LABORATORIES, INC. | 50 | 1% | CREAM |
PACKAGE FILES
Generic Name
SILVER SULFADIAZINE
Substance Name
SILVER SULFADIAZINE
Product Type
HUMAN PRESCRIPTION DRUG
Route
TOPICAL
Application Number
NDA018578
Description
DESCRPITION SSD™ (1% Silver Sulfadiazine Cream) and SSD AF™ (1% Silver Sulfadiazine Cream), 1% are topical antibacterial preparations which have as their active antimicrobial ingredient silver sulfadiazine. The active moiety is contained within an opaque, white, water miscible cream base. Each 1000 grams of SSD/SSD AF Cream contains 10 grams of silver sulfadiazine. Inactive Ingrediants: cetyl alcohol (SSD Cream only), isopropyl myristate, polyoxyl 40 stearate, propylene glycol, purified water, stearyl alcohol, sodium hydroxide, sorbitan monooleate, white petrolatum; with 0.3% methyl paraben, as a preservative. Silver sulfadiazine has an emprical formula of C 10 H 9 AgN 4 O 2 S, molecular weight of 357.14 and structural formula as shown: Structure for silver sulfadiazine
How Supplied
HOW SUPPLIED SSD™ (1% Silver Sulfadiazine) Cream : white to off-white cream. 50 gram jar NDC 43598-210-55 400 gram jar NDC 43598-210-40 25 gram tube NDC 43598-210-25 50 gram tube NDC 43598-210-50 85 gram tube NDC 43598-210-85 SSD AF™ (1% Silver Sulfadiazine) Cream : white to off-white cream. 50 gram jar NDC 43598-211-55 400 gram jar NDC 43598-211-40 Store at controlled room temperature 15° - 30°C (59° - 86°F) SSD is a trademark of Dr. Reddy's Laboratories, Inc. Manufactured by: Dr. Reddy's Laboratories Louisiana LLC Shreveport, LA 71106 USA Revised, June 2013
Indications & Usage
INDICATIONS AND USAGE Silver Sulfadiazine Cream 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: FOR TOPICAL USE ONLY - NOT FOR OPHTHALMIC USE: 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 is then applied under sterile conditions. The burn areas should be covered with Silver Sulfadiazine Cream 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 due to 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 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.