Oto End 10

In a non aqueous vehicle containing edetate disodium EDTA, Poloxamer 188, propylene glycol, propylene glycol diacetate, propylgallate, and purified water.

Topical corticosteroids are contraindicated in varicella, vaccinia and in patients sensitive to any of the components of this preparation. This medication should not be applied in the external auditory canal where there is a perforated eardrum or when this medication can reach the middle ear.

The following local adverse reactions have been reported with topical corticosteroids, especially under occlusive dressings: burning, itching, irritation, dryness, folliculitis, hypertrichosis, allergic contact dermatitis, skin atrophy, striae, and miliaria.

The external ear, that is the auricle and the auditory canal should be thoroughly cleansed and dried. Four (4) to 5 drops of Oto-End 10 Ear Drops should be instilled into the affected ear 3 or 4 times daily. For infants and small children, 3 drops are suggested because of the smaller capacity of the ear canal. The patient should lie with the affected ear upward to instill the drops and this position maintained for 5 minutes to facilitate penetration of the drops into the ear canal. Repeat, if necessary for the opposite affected ear. If preferred, a gauze ear plug or a wick may be inserted into the ear canal prior to applying Oto-End 10 Ear Drops. When using a wick, a few drops of sterile water should be applied directly to the wick following insertion to facilitate hydration. It should then be saturated with Oto-End 10 Ear Drops. The patient should be instructed to add a few drops of Oto-End 10 Ear Drops to the wick every four hours, and to remove the wick after 24 hours. Five (5) drops of Oto-End 10 Ear Drops should be instilled 3 or 4 times daily thereafter. When using a gauze ear plug, the external ear canal is first treated with drops of Oto-End 10 Ear Drops. Next, the gauze is inserted into the ear canal to contain the medication. The gauze ear plug or the expanded wick are easily removed using fingers, forceps, or tweezers. This product may be used in the unaffected ear 3 times daily as a preventative.

NDC 68047-051-10
Oto-End 10
10 mL bottle label

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Very bad ear irritation.
• Burning.
• Very bad itching.

• Store at room temperature.
• Protect from light.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.