GOODSENSE EAR WAX REMOVAL KIT- carbamide peroxide liquid

GoodSense Ear Wax Removal Kit by

Drug Labeling and Warnings

GoodSense Ear Wax Removal Kit by is a Otc medication manufactured, distributed, or labeled by Geiss, Destin & Dunn, Inc, Derma Care Research Labs, LLC, Derma Care Research Labs. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Carbamide Peroxide 6.5%

PURPOSE

Earwax removal aid

INDICATIONS & USAGE

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 the ear or are dizzy; consult a doctor
• if you have an injury or perforation (hole) in the ear drum or after ear surgery, unless directed by a doctor
• for more than 4 days; if excessive earwax remains after use of this product, consult a doctor

When using this product avoid contact with yes. If accidental contact with yes occurs, flush eyes with water and consult a doctor.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If the product is swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

FOR USE IN 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 INGREDIENT

Citric acid, glycerin, propylene glycol, sodium citrate, sodium lauryl sulfate, tartaric acid

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GOODSENSE EAR WAX REMOVAL KIT 
carbamide peroxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50804-117
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
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TARTARIC ACID (UNII: W4888I119H)
CITRIC ACID (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50804-117-01	1 in 1 BOX	05/01/2025
1		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 Drug	M014	05/01/2025

Labeler - Geiss, Destin & Dunn, Inc (076059836)

Registrant - Derma Care Research Labs, LLC (116817470)

Establishment
Name	Address	ID/FEI	Business Operations
Derma Care Research Labs		116817470	manufacture(50804-117)