WARNINGS:
The safe use of Erythromycin Topical Solution during pregnancy or lactation has not been established.
PRECAUTIONS:
General:
The use of antibiotic agents may be associated with the overgrowth of antibiotic-resistant organisms. If this occurs, administration of this drug should be discontinued and appropriate measures taken.
Information for Patients:
Erythromycin Topical Solution is for external use only and should be kept away from the eyes, nose, mouth and other mucous membranes. Concomitant topical acne therapy should be used with caution because a cumulative irritant effect may occur, especially with the use of peeling, desquamating or abrasive agents.
Carcinogenesis, Mutagenesis, Impairment of Fertility:
Long term animal studies to evaluate carcinogenic potential, mutagenicity, or the effect on fertility of erythromycin have not been conducted.
Pregnancy:
Pregnancy Category C. Animal reproduction studies have not been conducted with erythromycin. It is also not known whether erythromycin can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Erythromycin should be given to a pregnant woman only if clearly needed.
Nursing Mothers:
Erythromycin is excreted in breast milk. Caution must be exercised when erythromycin is administered to a nursing woman.
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