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warnings and cautions
5 WARNINGS AND PRECAUTIONS Accidental ingestion in pediatric patients may occur: Administer only under direct adult supervision. (5.1) 5.1 Ingestion in Pediatric Patients In order to prevent ingestion, SKLICE Lotion should only be administered to pediatric patients under the direct supervision of an adult.
6 ADVERSE REACTIONS Most common adverse reactions (incidence <1%) are conjunctivitis, ocular hyperemia, eye irritation, dandruff, dry skin, and skin burning sensation. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Sanofi Pasteur, Inc. at 1-800-835-3592 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The data described below reflect exposure to a single 10 minute treatment of SKLICE Lotion in 379 patients, ages 6 months and older, in placebo-controlled trials. Of these subjects, 47 subjects were age 6 months to 4 years, 179 subjects were age 4 to 12 years, 56 subjects were age 12 to 16 years and 97 subjects were age 16 or older. Adverse reactions, reported in less than 1% of subjects treated with SKLICE Lotion, include conjunctivitis, ocular hyperemia, eye irritation, dandruff, dry skin, and skin burning sensation.