HARRIS TEETER EARWAX REMOVAL DROPS- carbamide peroxide 6.5% liquid

Harris Teeter Earwax Removal Drops by

Drug Labeling and Warnings

Harris Teeter Earwax Removal Drops by is a Otc medication manufactured, distributed, or labeled by Harris Teeter LLC, Derma Care Research Labs, LLC. 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) of the eardrum 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 the eyes. If accidental contact with the eyes occurs, flush your eyes with water and consult a doctor.

KEEP OUT OF REACH OF CHILDREN

If product is swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

FOR IN EAR USE 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

HARRIS TEETER EARWAX REMOVAL DROPS 
carbamide peroxide 6.5% liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69256-117
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
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
TARTARIC ACID (UNII: W4888I119H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69256-117-01	1 in 1 CARTON	04/27/2022
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 final	part344	04/27/2022

Labeler - Harris Teeter LLC (048463103)

Registrant - Derma Care Research Labs, LLC (116817470)

Establishment
Name	Address	ID/FEI	Business Operations
Derma Care Research Labs, LLC		116817470	manufacture(69256-117)