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Name:Gentamicin Sulfate
Manufacturer:Physicians Total Care, Inc.
Category:Prescription Marketed Drugs


GENTAMICIN SULFATE  - gentamicin sulfate cream 
Physicians Total Care, Inc.

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Rx Only

DESCRIPTION

Each gram of GENTAMICIN CREAM contains gentamicin sulfate equivalent to 1 mg of gentamicin base in a cream base of: methylparaben, butylparaben, stearic acid, cerasynt PA (propylene glycol monostearate), isopropyl myristate, propylene glycol, polysorbate 40, sorbitol solution and water. Each gram of GENTAMICIN OINTMENT contains gentamicin sulfate 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, a wide spectrum antibiotic 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 OINTMENT AND CREAM 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 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 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, although regular observation of patients sensitive to topical antibiotics is advisable when such patients are treated with any topical antibiotic. GENTAMICIN CREAM is recommended for wet, oozing primary infections, and greasy, secondary infections, such as pustular acne or infected seborrheic dermatitis, and where a water washable cream preparation is desired. GENTAMICIN OINTMENT helps retain moisture and has been useful in infection on dry eczematous or psoriatic skin. GENTAMICIN CREAM and OINTMENT have been used successfully in infants over one year of age as well as in adults and children.

CONTRAINDICATIONS

This product, GENTAMICIN OINTMENT AND CREAM 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 should be discontinued and appropriate therapy instituted.

ADVERSE REACTIONS

In patients with dermatoses treated with GENTAMICIN, 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 OINTMENT or CREAM 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 OINTMENT or CREAM 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 under gelatin packing.

HOW SUPPLIED

GENTAMICIN CREAM is supplied in

15 gram tube
NDC 54868-3524-0
30 gram tube
NDC 54868-3524-1

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

MANUFACTURED
BY PERRIGO
BRONX, NY 10457

1C800 RC J2


Relabeling of "Additional" barcode label by:
Physicians Total Care, Inc.
Tulsa, OK       74146

PRINCIPAL DISPLAY PANEL

GENTAMICIN CREAM

30 gram

image of 30 gram package label


GENTAMICIN SULFATE 
gentamicin sulfate cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-3524(NDC:45802-056)
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GENTAMICIN SULFATE (GENTAMICIN) GENTAMICIN SULFATE 1 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
METHYLPARABEN  
BUTYLPARABEN  
STEARIC ACID  
PROPYLENE GLYCOL MONOSTEARATE  
ISOPROPYL MYRISTATE  
PROPYLENE GLYCOL  
POLYSORBATE 40  
SORBITOL  
WATER  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-3524-0 1 TUBE ( TUBE) in 1 CARTON contains a TUBE
1 15 g in 1 TUBE This package is contained within the CARTON (54868-3524-0)
2 NDC:54868-3524-1 1 TUBE ( TUBE) in 1 CARTON contains a TUBE
2 30 g in 1 TUBE This package is contained within the CARTON (54868-3524-1)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA062307 05/12/1995

Labeler - Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel

Revised: 03/2011 Physicians Total Care, Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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