Label: GENTAMICIN SULFATE cream
Contains inactivated NDC Code(s)
NDC Code(s): 54868-3524-0, 54868-3524-1
- Packager: Physicians Total Care, Inc.
- This is a repackaged label.
- Source NDC Code(s): 45802-056
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated March 9, 2011
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- SPL UNCLASSIFIED SECTION
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.
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.
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
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
gentamicin sulfate cream
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-3524(NDC:45802-056) Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GENTAMICIN SULFATE (UNII: 8X7386QRLV) (GENTAMICIN - UNII:T6Z9V48IKG) GENTAMICIN SULFATE 1 mg in 1 g Inactive Ingredients Ingredient Name Strength METHYLPARABEN (UNII: A2I8C7HI9T) BUTYLPARABEN (UNII: 3QPI1U3FV8) STEARIC ACID (UNII: 4ELV7Z65AP) PROPYLENE GLYCOL MONOSTEARATE (UNII: F76354LMGR) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POLYSORBATE 40 (UNII: STI11B5A2X) SORBITOL (UNII: 506T60A25R) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54868-3524-0 1 in 1 CARTON 1 15 g in 1 TUBE 2 NDC:54868-3524-1 1 in 1 CARTON 2 30 g in 1 TUBE 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 Business Operations Physicians Total Care, Inc. 194123980 relabel