GOODSENSE EAR WAX REMOVAL KIT- carbamide peroxide liquid

Drug Labeling and Warnings

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

Relabeled By: Preferred Pharmaceuticals Inc.

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: 68788-8615(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, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TARTARIC ACID (UNII: W4888I119H)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68788-8615-1	1 in 1 BOX	04/09/2026
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	04/09/2026

Labeler - Preferred Pharmaceuticals Inc. (791119022)

Registrant - Preferred Pharmaceuticals Inc. (791119022)

Establishment
Name	Address	ID/FEI	Business Operations
Preferred Pharmaceuticals Inc.		791119022	RELABEL(68788-8615)