Pramoxine-hc

Pramoxine-hc

Pramoxine-hc Recall

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Questions & Answers

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.

Pramoxine-hc Manufacturers


  • Ascend Laboratories, Llc
    Pramoxine-hc (Hydrocortisone / Chloroxylenol / Pramoxine Hcl) Solution/ Drops [Ascend Laboratories, Llc]

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