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Category Antibacterial. 

      Gentamicin Sulfate Cream contains the equivalent of not less than 90.0 per cent and not more than 135.0 per cent of the labelled amount of gentamicin.

Strength available 0.1 per cent w/w (base).

Dose Topical, to the skin, three or four times a day.

Warning It may cause hypersensitivity e.g. itching, redness, swelling, or other signs of irritation.

Additional information Water-washable cream of gentamicin sulfate may be useful in treating wet, oozing primary infections and greasy, secondary infections of the skin such as pustular acne or infected seborrheic dermatitis.

Packaging and storage Gentamicin Sulfate Cream shall be stored at a temperature not exceeding 30º. 

Labelling The label on the container states the quantity equivalent to the amount of gentamicin.

Identification Complies with the test for Identification C described under Gentamicin Sulfate, p. 111. Apply separately to the plate, 20 μl of each of the following solutions. For solution (A), disperse a portion of the cream, equivalent to 7.5 mg of gentamicin, in 20 ml of chloroform, extract with 10 ml of water and use the aqueous layer. Solution (B) is a solution of Gentamicin Sulfate RS containing the equivalent of 750 μg of gentamicin per ml.

Assay Shake an accurately weighed portion of Gentamicin Sulfate Cream, equivalent to about 1 mg of gentamicin, with 50 ml of ether, and extract with four 20-ml portions of Buffer 2. Combine the aqueous extracts, dilute quantitatively and stepwise with Buffer 2, and proceed as directed under the microbiological assay of Gentamicin Sulfate according to the “Microbiological Assay of Antibiotics” (Appendix 6.10).

Other requirements Comply with the requirements described under “Topical Semi-solid Preparations” (Appendix 1.16).