NDC 68788-8074 Ssd Cream

Silver Sulfadiazine

NDC Product Code 68788-8074

NDC CODE: 68788-8074

Proprietary Name: Ssd Cream What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Silver Sulfadiazine What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used with other treatments to help prevent and treat wound infections in patients with serious burns. Silver sulfadiazine works by stopping the growth of bacteria that may infect an open wound. This helps to decrease the risk of the bacteria spreading to surrounding skin, or to the blood where it can cause a serious blood infection (sepsis). Silver sulfadiazine belongs to a class of drugs known as sulfa antibiotics. Silver sulfadiazine must not be used on premature babies or on newborns during the first 2 months of life because of the risk of serious side effects.

NDC Code Structure

NDC 68788-8074-2

Package Description: 25 g in 1 TUBE

NDC 68788-8074-5

Package Description: 50 g in 1 TUBE

NDC Product Information

Ssd Cream with NDC 68788-8074 is a a human prescription drug product labeled by Preferred Pharmaceuticals Inc.. The generic name of Ssd Cream is silver sulfadiazine. The product's dosage form is cream and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates multiple RxCUI concepts are associated to this product: 106351 and 208185.

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Ssd Cream Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.


Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
  • PETROLATUM (UNII: 4T6H12BN9U)
  • POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
  • METHYLPARABEN (UNII: A2I8C7HI9T)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Sulfonamide Antibacterial - [EPC] (Established Pharmacologic Class)
  • Sulfonamides - [CS]

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Preferred Pharmaceuticals Inc.
Labeler Code: 68788
FDA Application Number: NDA018578 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: NDA - A product marketed under an approved New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 08-27-2021 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

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Ssd Cream Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

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 C10H9AgN4O2S, molecular weight of 357.14 and structural formula as shown:

Clinical Pharmacology

Silver sulfadiazine has broad antimicrobial activity.  It is bactericidal for many gram-negative and gram-positive bacteria as well as being effective against yeast.  Results from in vitro testing are listed below.  Sufficient data have been obtained to demonstrate that silver sulfadiazine will inhibit bacteria that are resistant to other antimicrobial agents and that the compound is superior to sulfadiazine.  Studies utilizing radioactive micronized silver sulfadiazine, electron microscopy, and biochemical techniques have revealed that the mechanism of action of silver sulfadiazine on bacteria differs from silver nitrate and sodium sulfadiazine.  Silver sulfadiazine acts only on the cell wall to produce its bactericidal effect.Results of In Vitro Testing With Silver Sulfadiazine Cream, 1% Concentration of Silver Sulfadiazine Number of Sensitive Strains / Total Number of Strains TestedGenus and Species                  50 micrograms/mL      100 micrograms/mLPseudomonas Aeruginosa            130/130                     130/130Xanthomonas (Pseudomonas)    Maltophilia                                 7/7                             7/7Enterobacter Species                   48/50                          50/50Enterobacter cloacae                   24/24                          24/24Klebsiella Species                       53/54                          54/54Escherichia Coli                          63/63                          63/63Serratia Species                         27/28                          28/28Proteus Mirabilis                        53/53                           53/53Morganella Morganii                   10/10                           10/10Providencia Rettgeri                    2/2                              2/2Proteus Vulgaris                         2/2                               2/2Providencia Species                    1/1                              1/1Citrobacter Species                   10/10                          10/10Acinetobacter Calcoaceticus      10/11                          11/11Stahylococcus Aureus             100/101                       101/101Staphylococcus Epidermidis      51/51                           51/51B-Hemolytic Streptococcus         4/4                              4/4Enterococcus Species              52/53                          53/53Corynebacterium Diphtheriae       2/2                               2/2Clostridium Perfringens               0/2                               2/2Clostridium Perfringens               0/2                               2/2Candida Albicans                    43/50                             50/50Silver sulfadiazine is not a carbonic anhydrase inhibitor and may be useful in situations where such agents are contraindicated.

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.

Contraindications

Silver Sulfadiazine Cream is contraindicated in patients who are hypersensitive to silver sulfadiazine or any of the other ingredients in the preparation.Because sulfonamide therapy is known to increase the possibility of kernicterus, Silver Sulfadiazine Cream should not be used on pregnant women approaching or at term, on premature infants, or on newborn infants during the first 2 months of life.

Warning

There is a potential cross-sensitivity between silver sulfadiazine and other sulfonamides.  If allergic reactions attributable to treatment with silver sulfadiazine occur, continuation of therapy must be weighed against the potential hazards of the particular allergic reaction.  Fungal proliferation in and below the eschar may occur.  However, the incidence of clinically reported fungal superinfection is low.The use of Silver Sulfadiazine Cream in some cases of glucose-6-phosphate dehydrogenase-deficient individuals may be hazardous, as hemolysis may occur.

Precaution

If hepatic and renal functions become impaired and elimination of the drug decreases accumulation may occur and discontinuation of Silver Sulfadiazine Cream should be weighed against the therapeutic benefit being achieved.In considering the use of topical proteolytic enzymes in conjunction with Silver Sulfadiazine Cream, the possibility should be noted that silver may inactivate such enzymes.Laboratory Tests: In the treatment of burn wounds involving extensive areas of the body, the serum sulfa concentrations may approach adult therapeutic levels (8 to 12mg %).  Therefore, in these patients it would be advisable to monitor serum sulfa concentrations.  Renal function should be carefully monitored and the urine should be checked for sulfa crystals.  Absorption of the propylene glycol vehicle has been reported to affect serum osmolality, which may affect the interpretation of laboratory tests.

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Long-term dermal toxicity studies of 24 months duration in rats and 18 months in mice with concentrations of silver sulfadiazine three to ten times the concentration in Silver Sulfadiazine Cream revealed no evidence of carcinogenicity.Pregnancy: Pregnancy Category B. A reproductive study has been performed in rabbits at doses up to three to ten times the concentration of silver sulfadiazine in Silver Sulfadiazine Cream and has revealed no evidence of harm to the fetus due to silver sulfadiazine.  There are, however, no adequate and well-controlled studies in pregnant women.  Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly justified, especially in pregnant women approaching or at term.  (See CONTRAINDICATIONS)Nursing Mother: It is not known whether Silver Sulfadiazine Cream is excreted in human milk.  However, sulfonamides are known to be excreted in human milk and all sulfonamides derivatives are known to increase the possibility of kernicterus.  Because of the potential for serious adverse reactions in nursing infants from sulfonamides, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.  Pediatric Use: Safety and effectiveness in children have not been established.  (See CONTRAINDICATIONS)

Adverse Reactions

Several cases of transient leucopenia have been reported in patients receiving silver sulfadiazine therapy.  Leucopenia associated with silver sulfadiazine administration is primarily characterized by decreased neutrophil count.  Maximal white blood cell depression occurs within two to four days of initiation of therapy.  Rebound to normal leukocyte levels follows onset within two to three days.  Recovery is not influenced by continuation of silver sulfadiazine therapy.  The incidence of leucopenia in various reports averages about 20%.  A higher incidence has been seen in patients treated concurrently with cimetidine.Other infrequently occurring events include skin necrosis, erythema multiforme, skin discoloration, burning sensation, rashes, and interstitial nephritis.  Reduction in bacterial growth after application of topical antibacterial agents has been reported to permit spontaneous healing of deep partial thickness burns by preventing conversion of the partial thickness to full thickness by sepsis.  However, reduction in bacterial colonization has caused delayed separation, in some cases necessitating escharotomy in order to prevent contracture.Absorption of silver sulfadiazine varies depending upon the percent of body surface area and the extent of the tissue damage.  Although few have been reported, it is possible that any adverse reaction associated with sulfonamides may occur.  Some of the reactions which have been associated with sulfonamides are as follows: blood dyscrasias, agranulocytosis, aplastic anemia, thrombocytopenia, leucopenia, hemolytic anemia, dermatologic reactions, allergic reactions, Stevens-Johnson syndrome, exfoliative dermatitis, gastrointestinal reactions, hepatitis, hepatocellular necrosis, CNS reactions, and toxic nephrosis.

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.

How Supplied

SSD™ (1% Silver Sulfadiazine) Cream: white to off-white cream.50 gram jar                     NDC 68788-8074- 525 gram tube                     NDC 68788-8074-2Store 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 LLCShreveport, LA 71106 USARevised, June 2013Relabeled By: Preferred Pharmaceuticals Inc.

Container Label For 25 G Tube

SSD™NDC 43598-210-25 Dr. Reddy’s25 Grams1% Silver Sulfadiazine Cream 1% FOR TOPICAL USE ONLYNOT FOR OPHTHALMIC USE Rx Only Silver Sulfadiazine…10mg/gin a hydrophilic base consisting of cetyl alcohol, isopropyl myristate, polyoxyl 40 stearate, propylene glycol, purified water, stearyl alcohol, sodium hydroxide, sorbitan monooleate, white petrolatum; with 0.3% methylparaben, as a preservative. See full prescribing information for dosage and administration. Store at controlled room 15° - 30°C (59° - 86°F). SSD is a trademark of Dr. Reddy’s Laboratories, Inc. Manufactured by Dr. Reddy's Laboratories Louisiana, LLCShreveport, LA 71106 USARelabeled By: Preferred Pharmaceuticals Inc.

* Please review the disclaimer below.