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Otic Edge

Generic Name: acetic acid, antipyrine, benzocaine
Dosage Form: ear drops

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.

Otic Edge Otic Solution

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 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:
Warm to body temperature (37°C or 98°F) by holding the bottle in hand for a few minutes. Administer the product allowing the solution to cover the wall of the canal until it is filled. Avoid touching the ear with dropper. Next, moisten a cotton swab with the product and insert into the opening of the ear canal. Repeat every one to two hours until pain and congestion are relieved.

Removal of earwax:
Administer three times daily for two or three days to help detach earwax from wall of canal. Otic Edge Otic Solution can help dry out the canal to relieve discomfort. Before and after removal of earwax, a cotton swab moistened with the product should be inserted into the opening of the ear canal following application.

HOW SUPPLIED:

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).

WARNING: KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN.

STORAGE:

Store at 20-25°C (68-77°F). See USP controlled room temperature.
Protect from freezing. Keep container tightly closed.

Manufactured for:
River’s Edge Pharmaceuticals, LLC
Suwanee, GA 30024
Iss. 09/08 328-11

PACKAGING:

Otic Edge 
acetic acid, antipyrine, benzocaine, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68032-328
Route of Administration AURICULAR (OTIC) DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETIC ACID (ACETIC ACID) ACETIC ACID 100 ug  in 1 mL
ANTIPYRINE (ANTIPYRINE) ANTIPYRINE 54 mg  in 1 mL
BENZOCAINE (BENZOCAINE) BENZOCAINE 14 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
ALUMINUM ACETATE  
ALUMINUM OXIDE  
GLYCERIN  
Packaging
# Item Code Package Description
1 NDC:68032-328-14 14 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 09/01/2008 09/30/2012
Labeler - River's Edge Pharmaceuticals, LLC (133879135)
Revised: 12/2010
 
River's Edge Pharmaceuticals, LLC



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