NDC 70518-2373 Ssd Cream

Silver Sulfadiazine

NDC Product Code 70518-2373

NDC CODE: 70518-2373

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

  • 70518 - Remedyrepack Inc.

NDC 70518-2373-0

Package Description: 25 g in 1 TUBE

NDC Product Information

Ssd Cream with NDC 70518-2373 is a a human prescription drug product labeled by Remedyrepack Inc.. The generic name of Ssd Cream is silver sulfadiazine. The product's dosage form is cream and is administered via topical form.

Labeler Name: Remedyrepack Inc.

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.

  • SILVER SULFADIAZINE 10 g/1000g

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.
  • 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: Remedyrepack Inc.
Labeler Code: 70518
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: 10-21-2019 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: 12-31-2020 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 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. Values = ‘Y’ or ‘N’.

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Information for Patients

Silver Sulfadiazine

Silver Sulfadiazine is pronounced as (sil' ver sul fa dye' a zeen)

Why is silver sulfadiazine medication prescribed?
Silver sulfadiazine, a sulfa drug, is used to prevent and treat infections of second- and third-degree burns. It kills a wide variety of bacteria.This medication is somet...
[Read More]

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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
C


10H


9AgN


4O


2S, 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 Tested


Genus 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 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

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