GOOD NEIGHBOR PHARMACY EAR SYSTEM- carbamide peroxide solution/ drops

Good Neighbor Pharmacy Ear System by

Drug Labeling and Warnings

Good Neighbor Pharmacy Ear System by is a Otc medication manufactured, distributed, or labeled by AmerisourceBergen Drug Corporation, Product Quest Mfg, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Active ingredient                                            Purpose

Carbamide Peroxide 6.5%..............................Softens & removes wax

Purpose

Softens & removes wax

Uses

For occasional use as an aid to soften, loosen, and remove

excessive ear wax.

Warnings

Do Not Use

if you have ear drainage or discharge, ear pain, irritation or rash

in the ear, or are dizzy; consult a doctor.

if you have an injury or perforation (hole) of the eardrum or after

ear surgery, unless directed by a doctor.

for more than four consecutive days.

When using this product

avoid contact with the eyes.

Stop use and ask a doctor if

excessive ear wax remains after

use of this product for four consecutive days.

Keep out of reach of children.

If swallowed, get medical help or

contact a Poison Control Center right away. If accidental contact

with eyes occurs, flush eyes with water and consult a doctor.

Directions

FOR USE IN THE EAR ONLY. Adults and children over 12 years of

age: tilt head sideways and place 5 to 10 drops into ear. Tip of

applicator should not enter ear canal. Keep drops in ear for several

minutes by keeping head tilted or placing cotton in ear. Use twice

daily for up to four days if needed, or as directed by a doctor. Any

wax remaining after treatment may be removed by gently flushing

the ear with warm water, using a soft rubber bulb ear syringe.

Children under 12 years of age: consult a doctor.

Other information

Protect from heat and direct sunlight.

Keep cap on bottle when not in use.

Inactive ingredients

Glycerin, Oxyquinoline.

SPL UNCLASSIFIED SECTION

Distributed By

AmerisourceBergen

1300 Morris Drive

Chesterbrook, PA 19087

Visit us at

www.goodneighborpharmacy.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GOOD NEIGHBOR PHARMACY EAR SYSTEM 
carbamide peroxide solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24385-503
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	CARBAMIDE PEROXIDE	6.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
OXYQUINOLINE (UNII: 5UTX5635HP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24385-503-05	15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part344	04/15/2003

Labeler - AmerisourceBergen Drug Corporation (007914906)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg, LLC		927768135	manufacture(24385-503) , label(24385-503)