EAR SYSTEM GNP- carbamide peroxide 6.50% kit

Ear System by

Drug Labeling and Warnings

Ear System by is a Otc medication manufactured, distributed, or labeled by Amerisource Bergen, Product Quest Mfg, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient                     Purpose

Carbamide Peroxide 6.5%        Softens & removes wax

PURPOSE

Uses

For occasional use as an aid 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.
When using this product avoid contact with eyes

Stop use and ask a doctor if excessive earwax remains after use of this product for four consecutive days

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of the children
If product is swallowed, get medical help or contact a Poison Control Center right away
In case of accidental ingestion, seek professional or contact a Poison Control Center immediately.

DirectionsDirections 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 the ear
use twice daily for up to 4 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.

Inactive ingredients

Glyceryn, Oxyquinoline

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EAR SYSTEM  GNP
carbamide peroxide 6.50% kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24385-501

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24385-501-07	1 in 1 KIT; Type 0: Not a Combination Product	10/15/2003

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE	15 mL

Part 1 of 1

WAX REMOVAL SYSTEM 
carbamide peroxide 6.50% solution/ drops

Product Information
Item Code (Source)	NDC: 24385-500
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
GLYCERIN (UNII: PDC6A3C0OX)
OXYQUINOLINE SULFATE (UNII: 61VUG75Y3P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24385-500-01	15 mL in 1 BOTTLE; 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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part344	10/15/2003

Labeler - Amerisource Bergen (007914906)

Registrant - Product Quest Mfg, LLC (927768135)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg, LLC		927768135	manufacture(24385-500, 24385-501) , label(24385-500, 24385-501)