FDA records indicate that there are no current recalls for this drug.
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Side Effects & Adverse Reactions
WARNINGS:
The product should be used with care in cases of long-standing otitis media because of the possible perforation of the eardrum concomitant with the external ear use of this product. This product is not intended for ophthalmic or oral use. If irritation or sensitization occurs, promptly discontinue use of this otic solution and institute other measures.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
INDICATIONS AND USAGE:
For the treatment of superficial infections of the external ear caused by microbes and to control the accompanying itching.
History
There is currently no drug history available for this drug.
Other Information
DESCRIPTION:
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.
Sources
Pramoxine-hc Manufacturers
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Ascend Laboratories, Llc
Pramoxine-hc | Ascend Laboratories, Llc
DOSAGE AND 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.
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