EAR DROPS- carbamide peroxide 6.5% liquid
Good Sense

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredient Purpose

Carbamide peroxide 6.5% Earwax removal aid

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

Warnings

Do not use if you have • ear drainage or discharge • ear pain • irritation or rash in ear • dizziness • an injury or perforation (hole) of the eardrum • recently had ear surgery

When using this product avoid contact with eyes

Keep out of reach of children

DirectionsFor 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.

Citric Acid, Flavor, Glycerin, Propylene Glycol, Sodium Lauroyl Sarcosinate, Sodium Stannate, Water

Questions?
1-866-483-2846

image description

EAR DROPS
carbamide peroxide 6.5% liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50804-508
Route of Administration	AURICULAR (OTIC)

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

Ingredient Name	Strength
Inactive Ingredients
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
Glycerin (UNII: PDC6A3C0OX)
Propylene Glycol (UNII: 6DC9Q167V3)
Sodium Lauroyl Sarcosinate (UNII: 632GS99618)
Sodium Stannate (UNII: NJ7C1V83KG)
Water (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:50804-508-01	1 in 1 CARTON	09/01/2017
1		15 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part344	09/01/2017

Labeler - Good Sense (076059836)

Registrant - Product Quest Mfg. (927768135)

Name	Address	ID/FEI	Business Operations
Establishment
Product Quest Mfg.		927768135	manufacture(50804-508) , label(50804-508)

Drug Facts

Active ingredient Purpose

Warnings

Questions?1-866-483-2846

Questions?
1-866-483-2846