Label: GENTAMICIN SULFATE ointment

  • NDC Code(s): 52565-090-15, 52565-090-30
  • Packager: Teligent Pharma, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 2, 2018

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Rx Only

    For Dermatologic Use Only

    Not for Ophthalmic Use

  • DESCRIPTION

    Gentamicin Sulfate Ointment USP, 0.1% is a wide spectrum antibiotic preparation for topical administration. Each gram of Gentamicin Sulfate Ointment USP, 0.1% contains Gentamicin Sulfate USP equivalent to 1 mg of gentamicin base in a base of light mineral oil and white petrolatum, with 0.5 mg methylparaben and 0.1 mg propylparaben as preservatives.

  • CLINICAL PHARMACOLOGY

    Gentamicin Sulfate is a wide spectrum antibiotic that provides highly effective topical treatment in primary and secondary bacterial infections of the skin. This product may clear infections that have not responded to other topical antibiotic agents. In impetigo contagiosa and other primary skin infections, treatment with a small amount of Gentamicin Sulfate Ointment three to four times daily usually clears the lesions promptly. In secondary skin infections, the product facilitates the treatment of the underlying dermatosis by controlling the infection. Bacteria susceptible to the action of Gentamicin Sulfate include sensitive strains of Streptococci (group A beta-hemolytic, alpha-hemolytic), Staphylococcus aureus (coagulase positive, coagulase negative, and some penicillinase-producing strains), and the gram-negative bacteria, Pseudomonas aeruginosa, Aerobacteraerogens, Escherichia coli, Proteus vulgaris and Klebsiellapneumoniae.

  • INDICATIONS AND USAGE

    Primary skin infections: Impetigo contagiosa, superficial folliculitis, ecthyma, furunculosis, sycosis barbae, and pyoderma gangrenosum. Secondary skin infections: Infectious eczematoid dermatitis, pustular acne, pustular psoriasis, infected seborrheic dermatitis, infected contact dermatitis (including poison ivy), infected excoriations, and bacterial superinfections of fungal or viral infections. NOTE: Gentamicin Sulfate is a bactericidal agent that is not effective against viruses or fungi in skin infections. It is useful in the treatment of infected skin cysts and certain other skin abscesses when preceded by incision and drainage to permit adequate contact between the antibiotic and the infecting bacteria. Good results have been obtained in the treatment of infected stasis and other skin ulcers, infected superficial burns, paronychia, infected insect bites and stings, infected lacerations and abrasions and wounds from minor surgery. Patients sensitive to neomycin can be treated with Gentamicin Sulfate, although regular observation of patients sensitive to topical antibiotics is advisable when such patients are treated with any topical antibiotic. Gentamicin Sulfate Ointment USP, 0.1% helps retain moisture and has been useful in infection on dry eczematous or psoriatic skin. Gentamicin Sulfate Ointment USP, 0.1% has been used successfully in infants over one year of age as well as in adults and children.

  • CONTRAINDICATIONS

    Gentamicin Sulfate Ointment USP, 0.1% is contraindicated in individuals with a history of sensitivity reactions to any of its components.

  • PRECAUTIONS

    Use of topical antibiotics occasionally allows overgrowth of nonsusceptible organisms, including fungi. If this occurs, or if irritation, sensitization, or superinfection develops, treatment with Gentamicin Sulfate Ointment USP, 0.1% should be discontinued and appropriate therapy instituted.

  • ADVERSE REACTIONS

    In patients with dermatoses treated with Gentamicin Sulfate, irritation (erythema and pruritus) that did not usually require discontinuance of treatment has been reported in a small percentage of cases. There was no evidence of irritation or sensitization, however, in any of these patients patch-tested subsequently with gentamicin on normal skin. Possible photosensitization has been reported in several patients but could not be elicited in these patients by reapplication of gentamicin followed by exposure to ultraviolet radiation.

    To report SUSPECTED ADVERSE REACTIONS, contact Teligent Pharma, Inc. at 1-856-697-1441, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

  • DOSAGE AND ADMINISTRATION

    A small amount of Gentamicin Sulfate Ointment USP, 0.1% should be applied gently to lesions three to four times a day. The area treated may be covered with a gauze dressing, if desired. In impetigo contagiosa, the crusts should be removed before application of Gentamicin Sulfate Ointment USP, 0.1% to permit maximum contact between the antibiotic and the infection. Care should be exercised to avoid further contamination of the infected skin. Infected stasis ulcers have responded well to Gentamicin Sulfate under gelatin packing.

  • HOW SUPPLIED

    Gentamicin Sulfate Ointment USP, 0.1% is available as follows:

    15 g tube (NDC 52565-090-15)

    30 g tube (NDC 52565-090-30)

  • STORAGE

    Store at 20 to 25˚C (68 to 77˚F) [see USP Controlled Room Temperature].

  • SPL UNCLASSIFIED SECTION

    Manufactured By:

    Teligent Pharma, Inc.
    Buena, NJ 08310

    Revised: 04/2018

  • Principal Display Panel - Carton

    NDC 52565-090-15

    Gentamicin Sulfate

    Ointment USP, 0.1%*

    Net Wt. 15 grams

    Rx only

    For External Use Only
    Not For Ophthalmic Use

    15 g carton PDP
  • INGREDIENTS AND APPEARANCE
    GENTAMICIN SULFATE 
    gentamicin sulfate ointment
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:52565-090
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GENTAMICIN SULFATE (UNII: 8X7386QRLV) (GENTAMICIN - UNII:T6Z9V48IKG) GENTAMICIN1 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52565-090-151 in 1 CARTON12/31/2018
    115 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:52565-090-301 in 1 CARTON12/31/2018
    230 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20923312/31/2018
    Labeler - Teligent Pharma, Inc. (011036910)
    Registrant - Teligent Pharma, Inc. (011036910)
    Establishment
    NameAddressID/FEIBusiness Operations
    Teligent Pharma, Inc.011036910manufacture(52565-090)