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----------OTIC EDGE Otic Solution
Each mL contains:
CLINICAL PHARMACOLOGY:Otic Edge Otic Solution combines the properties of acetic acid, policosanol and aluminum acetate with the analgesic action of antipyrine and the local anesthetic action of benzocaine to alleviate pain and discomfort in acute otitis media while also relieving pressure, reducing inflammation and congestion. Does not discolor the tympanic membrane or distort clinical manifestations which could obscure a clinical presentation.
INDICATIONS AND USAGE:Acute otitis media:
• Rapid pain relief and reduction of inflammation in the congestive and serous stages of otitis media.
• Adjuvant therapy during systemic antibiotic administration.
Removal of earwax:
• Facilitates the removal of excessive or impacted earwax.
CONTRAINDICATIONS:• Hypersensitivity to any of the components or substances related to Otic Edge Otic Solution.
• In case of tympanic membrane perforation or discharge.
PRECAUTIONS:Carcinogenesis, Mutagenesis, Impairment of Fertility: No long-term studies in animals or humans have been conducted.
Pregnancy Category C: Animal reproduction studies have not been conducted with this preparation. It is also not known whether this product can cause fetal harm when administered to a pregnant woman, or can affect reproduction capacity. This product should be given to a pregnant woman only if clearly needed. Consult your physician.
Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this product is administered to a nursing woman. Consult your physician.
ADVERSE REACTIONS:Call your doctor for medical advice about side effects. You may report suspected side effects to the FDA at 1-800-FDA-1088.
DOSAGE AND ADMINISTRATION:
Acute otitis media:
14 mL of Otic Edge Otic Solution ear drops are supplied in a white plastic bottle with separate dropper with screw cap attachment and package insert, (NDC 68032-328-14).
Revised: 12/2010 River's Edge Pharmaceuticals, LLC
Reproduced with permission of U.S. National Library of Medicine
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