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    GENTAMICIN SULFATE-gentamicin S Ulfate Ointment Perrigo New York Inc

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    Rezki Nafi
    This document provides information on Gentamicin Sulfate Ointment USP, 0.1%, an antibiotic ointment for topical dermatological use. It contains gentamicin sulfate which is effective against common skin pathogens. The ointment is intended to treat primary and secondary bacterial skin infections when applied 3-4 times daily. Common side effects are rare and mild irritation in some patients.

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    © All Rights Reserved
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    GENTAMICIN SULFATE-gentamicin S Ulfate Ointment Perrigo New York Inc

    Uploaded by

    Rezki Nafi
    29 views4 pages
    This document provides information on Gentamicin Sulfate Ointment USP, 0.1%, an antibiotic ointment for topical dermatological use. It contains gentamicin sulfate which is effective against common skin pathogens. The ointment is intended to treat primary and secondary bacterial skin infections when applied 3-4 times daily. Common side effects are rare and mild irritation in some patients.

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    This document provides information on Gentamicin Sulfate Ointment USP, 0.1%, an antibiotic ointment for topical dermatological use. It contains gentamicin sulfate which is effective against common skin pathogens. The ointment is intended to treat primary and secondary bacterial skin infections when applied 3-4 times daily. Common side effects are rare and mild irritation in some patients.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    29 views4 pages

    GENTAMICIN SULFATE-gentamicin S Ulfate Ointment Perrigo New York Inc

    Uploaded by

    Rezki Nafi
    This document provides information on Gentamicin Sulfate Ointment USP, 0.1%, an antibiotic ointment for topical dermatological use. It contains gentamicin sulfate which is effective against common skin pathogens. The ointment is intended to treat primary and secondary bacterial skin infections when applied 3-4 times daily. Common side effects are rare and mild irritation in some patients.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 4

    GENTAMICIN SULFATE- gentamicin s ulfate ointment

    Perrigo New York Inc


    ----------
    Gentamicin Sulfate Ointment USP, 0.1%
    Rx Only
    For Dermatologic Us e Only
    Not for Ophthalmic Us e

    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, Aerobacter aerogens, 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 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 cream is recommended for wet, oozing primary infections, and
    greasy, secondary infections, such as postular acne or infected seborrheic dermatitis. 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.

    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 45802-046-35)
    30 g tube (NDC 45802-046-11)

    STORAGE
    Store at 20-25˚C (68-77˚F) [see USP Controlled Room Temperature].
    Manufactured By Perrigo
    Bronx, NY 10457
    Distributed By Perrigo
    Allegan, MI 49010 • www.perrigo.com
    Rev. 10/12
    :1C800 RC J5

    Principal Dis play Panel - Carton


    Rx Only
    Gentamicin Sulfate Ointment USP, 0.1%
    NET WT 15 g
    The following image is a placeholder representing the product identifier that is either affixed or
    imprinted on the drug package label during the packaging operation.

    GENTAMICIN SULFATE
    gentamicin sulfate ointment

    Product Information
    Prod uct T yp e HUMAN PRESCRIPTIO N DRUG Ite m Cod e (S ource ) NDC:458 0 2-0 46

    Route of Ad minis tration TO PICAL

    Active Ing redient/Active Moiety


    Ing redient Name Basis o f Streng th Streng th
    GENTAMICIN SULFATE (UNII: 8 X738 6 Q RLV) (GENTAMICIN - UNII:T6 Z9 V48 IKG) GENTAMICIN 1 mg in 1 g

    Inactive Ing redients


    Ing redient Name Streng th
    LIGHT MINERAL O IL (UNII: N6 K578 7Q VP)
    PETRO LATUM (UNII: 4T6 H12BN9 U)
    METHYLPARABEN (UNII: A2I8 C7HI9 T)
    PRO PYLPARABEN (UNII: Z8 IX2SC1O H)

    Packag ing
    # Item Co de Packag e Descriptio n Marketing Start Date Marketing End Date
    1 NDC:458 0 2-0 46 -35 1 in 1 CARTO N 0 7/10 /20 0 6
    1 15 g in 1 TUBE; Type 0 : No t a Co mbina tio n Pro duc t
    2 NDC:458 0 2-0 46 -11 1 in 1 CARTO N 0 8 /28 /20 0 6
    2 30 g in 1 TUBE; Type 0 : No t a Co mbina tio n Pro duc t

    Marketing Information
    Marke ting Cate gory Ap p lication Numb e r or Monograp h Citation Marke ting S tart Date Marke ting End Date
    ANDA ANDA0 6 2351 0 7/10 /20 0 6

    Labeler - Perrigo New York Inc (078846912)

    Revised: 11/2018 Perrigo New York Inc

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