Label: GENTAMICIN SULFATE CREAM 0.1% cream

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 7, 2020

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

  • DESCRIPTION

    Gentamicin Sulfate Cream is a wide spectrum antibiotic preparation for topical administration. Each gram contains Gentamicin Sulfate USP equivalent to 1 mg gentamicin base in a cream base containing stearic acid, propylene glycol monostearate, isopropyl myristate, polysorbate 40, propylene glycol, sorbitol solution and purified water with methylparaben and butylparaben 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. Gentamicin Sulfate Cream may clear infections that have not responded to treatment with other topical antibiotic agents. In primary skin infections such as impetigo contagiosa, treatment 3 or 4 times daily with Gentamicin Sulfate Cream usually clears the lesions promptly. In secondary skin infections, Gentamicin Sulfate Cream aids in the treatment of the underlying dermatoses

    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, Aerobacter aerogenes, Escherichia coli, Proteus vulgaris, and Klebsiella pneumoniae

  • 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 super-infections of fungal or viral

    infections. Please Note: Gentamicin Sulfate is a bactericidal agent that is not effective against viruses or fungi in skin infections. Gentamicin Sulfate 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 Cream is recommended for wet, oozing primary infections, and greasy, secondary infections, such as pustular acne or infected seborrheic dermatitis. If a water-washable preparation is desired, the cream is preferable. Gentamicin Sulfate Cream has been used successfully in infants over one year of age, as well as in adults and children.

  • CONTRAINDICATIONS

    This drug product is contraindicated in individuals with a history of sensitivity to any of its components.

  • PERCAUTIONS

    The use of topical antibiotics occasionally allows overgrowth of nonsusceptible organisms, including fungi. If this condition occurs, or if irritation, sensitization or superinfection develops, treatment with gentamicin sulfate should be discontinued and appropriate therapy instituted.

  • ADVERSE REACTIONS

    In patients with dermatoses treated with Gentamicin Sulfate, irritation (erythema and pruritis) 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 Sulfate on normal skin. Possible photosensitization has been reported in several patients but could not be elicited in these patients by reapplication of Gentamicin Sulfate 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 Cream should be applied gently to the lesions three or four times daily. 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 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 treatment with gentamicin sulfate under gelatin packing.

  • HOW SUPPLIED

    Gentamicin Sulfate Cream USP, 0.1% is supplied as follows:

    30 gram tube (NDC 70512-036-30)

    Store at controlled room temperature 15°-30°C (59°-86°F).

    Manufactured for:

    SOLA Pharmaceuticals

    Baton Rouge, LA 70810

    C101322

    PI-036-00

    Rev 12/2019

    Rev. 2

  • PACKAGE LABEL PRINCIPAL DISPLAY PANEL

    NDC 70512-036-30

    Gentamicin Sulfate

    Cream USP, 0.1%

    For Dermatological Use Only

    Not for Ophthalmic Use

    Keep this and all drugs out of the reach of children.

    30 grams

    Rx only

    Sola Pharmaceuticals

    Gentamicin Tube DisplayGentamicin Carton Display

  • INGREDIENTS AND APPEARANCE
    GENTAMICIN SULFATE CREAM 0.1% 
    gentamicin sulfate cream 0.1% cream
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70512-036
    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
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    PROPYLENE GLYCOL MONOPALMITOSTEARATE (UNII: F76354LMGR)  
    POLYSORBATE 40 (UNII: STI11B5A2X)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70512-036-301 in 1 CARTON04/07/2020
    130 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20930404/07/2020
    Labeler - Sola Pharmaceuticals (080121345)