EARWAX REMOVAL DROPS- carbamide peroxide 6.5% liquid

Earwax Removal Drops by

Drug Labeling and Warnings

Earwax Removal Drops by is a Otc medication manufactured, distributed, or labeled by Randob Labs, Ltd., Pharma Nobis, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DOSAGE & ADMINISTRATION

FOR USE IN THE EAR ONLY

Adults & Children over 12 yrs of age:

Tilt head to the side and place 5-10 drops into ear.

Dropper tip of removal drops 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 four days if needed, or as directed by a doctor.

Safely scoop out wax with removal tool.

Any wax remaining after treatment may be removed by gently flushing the ear with warm water, using the ear bulb syringe.

Children under 12 yrs of age:

Consult a doctor.

INDICATIONS & USAGE

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

PURPOSE

Earwax Removal Aid

ACTIVE INGREDIENT

Carbamide Peroxide 6.5%

INACTIVE INGREDIENT

Aloe Barbadensis Leaf Extract

Chamomilla Recutita (Matricaria) Flower Extract

Glycerin

Mineral Oil

Oxyquinoline Sulfate

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1212) right away.

WHEN USING

When using this product avoid contact with eyes.

STOP USE

Stop use and ask a doctor if:

you need to use more than four days

excessive earwax remains after use of this product

OTHER SAFETY INFORMATION

Other Information

Do not use if neck wrap imprinted safety seal is broken or missing

Do not store above 25 degrees C, 77 degrees F

Store bottle in outer carton

Keep cap on bottle when not in use

Product foams on contacy with earwax due to release of oxygen

WARNINGS

Warnings

Ask a doctor before use 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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EARWAX REMOVAL DROPS 
carbamide peroxide 6.5% liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52412-600
Route of Administration	AURICULAR (OTIC)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	CARBAMIDE PEROXIDE	0.065 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CHAMOMILE (UNII: FGL3685T2X)
OXYQUINOLINE SULFATE (UNII: 61VUG75Y3P)
MINERAL OIL (UNII: T5L8T28FGP)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52412-600-05	1 in 1 CARTON	07/03/2020
1		15 mL in 1 BOTTLE, DROPPER; 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	07/03/2020

Labeler - Randob Labs, Ltd. (061995007)

Registrant - Pharma Nobis, LLC (118564114)

Establishment
Name	Address	ID/FEI	Business Operations
Pharma Nobis, LLC		118564114	manufacture(52412-600) , analysis(52412-600) , label(52412-600) , pack(52412-600)