Otic Edge

Generic name: acetic acid, antipyrine, benzocaine
Dosage form: ear drops
Drug class:Otic anesthetics

Medically reviewed by Drugs.com. Last updated on Nov 22, 2021.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

DESCRIPTION:

Each mL contains:
Acetic Acid .....0.01%
Antipyrine ..... 5.4%
Benzocaine.....1.4%
Policosanol.....0.01%

INACTIVE INGREDIENTS: Aluminum Acetate, Aluminum Oxide, Glycerin.

TOPICAL ANESTHETIC, ANALGESIC AND ANTIBACTERIAL: Otic Edge Otic Solution contains acetic acid, antipyrine, benzocaine, policosanol, aluminum acetate, aluminum oxide, glycerin. The solution congeals at 0ºC (32ºF) but returns to normal consistency, unchanged at room temperature.

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