Drug Catalog - Product Detail
HYDROCORTISONE ACETATE/PRAMOXINE HCL/CHLOROXLENOL OTIC SOLN. SOL 10/10/1MG/ML 10ML
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 67877-0269-11 | ASCEND LABORATORIES | 10ML | 10-10-1MG/ML | NA |
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Description
DESCRIPTION RX only Each 1 mL for otic administration contains: Hydrocortisone ......................................10 mg Chloroxylenol ...........................................1 mg Pramoxine HCl .......................................10 mg Inactive ingredients: In an aqueous vehicle containing Isopropyl Alcohol and Propylene Glycol. Hydrocortisone (cortisol)(11ß, 17,21-trihydroxy pregn-4-ene-3,20-dione)is an anti-inflammatory and antipruritic agent. Chloroxylenol is a broad spectrum bactericidal agent which occurs as white crystals with a phenolic odor. It is soluble in alcohol, ether and alkali hydroxides. Chemically it is (4-chloro-3,5-dimethyl phenol or meta-chloroxylenol). Pramoxine (4-[3-(butoxyphenoxy)propyl-]morpholine), used as the hydrochloride salt, is a topical anesthetic.
How Supplied
HOW SUPPLIED Pramoxine-HC Otic Drops are supplied as a clear liquid in 10 mL plastic dropper bottles, NDC 67877-269-11. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY. STORAGE: Protect from light, dispense in original container. Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). Manufactured for: Ascend Laboratories, LLC Montvale, NJ 07645 Rev. 04/16
Indications & Usage
INDICATIONS & USAGE For the treatment of superficial infections of the external ear caused by microbes and to control the accompanying itching.
Dosage and Administration
DOSAGE & ADMINISTRATION The external ear and the ear canal should be thoroughly cleaned and dried. Four (4) to five (5) drops of Pramoxine-HC Otic Drops should be administered into the affected ear, 3 to 4 times daily. For infants and small children, three (3) drops are suggested because of the smaller ear canal. The patient should lie with the affected ear upward to administer the drops and remain in this position for at least 5 minutes to help the drops flow into the ear canal. Repeat in the opposite affected ear, if necessary. A gauze ear plug may be used, if preferred. Drops of Pramoxine-HC Otic Drops may be added to the gauze ear plug 3 or 4 times daily to keep the ear plug moist. The ear plug should be removed after one day of use. The gauze ear plug should be easily removed using fingers, forceps or tweezers.