ERO EAR WAX REMOVAL KIT- carbamide peroxide 6.5% liquid

ERO Ear Wax Removal Kit by

Drug Labeling and Warnings

ERO Ear Wax Removal Kit by is a Otc medication manufactured, distributed, or labeled by Randob Labs, 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

Ask a doctor before use if you have

• if you have ear drainage or discharge, ear pain, irritation or rash in the ear, dizziness
• an injury or perforation (hole) of the eardrum, recently had ear surgery

When using this product avoid contact with the eyes

Stop use and ask a doctor if you need to use for more than four days, excessive earwax remains after use of this product.

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

Aloe Barbadensis Extract, Chamomilla Recutita (Matricaria) Flower Extract, Citric Acid, Glycerin, Propylene Glycol, Sodium Citrate, Sodium Lauryl Sulfate, Tartaric Acid.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ERO EAR WAX REMOVAL KIT 
carbamide peroxide 6.5% liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52412-175
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
CHAMOMILE (UNII: FGL3685T2X)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TARTARIC ACID (UNII: W4888I119H)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52412-175-01	1 in 1 CARTON	04/16/2021
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	04/16/2021

Labeler - Randob Labs (061995007)

Registrant - Derma Care Research Labs, LLC (116817470)

Establishment
Name	Address	ID/FEI	Business Operations
Derma Care Research Labs, LLC		116817470	manufacture(52412-175)