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 CVS Pharmacy, Pharma Nobis, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DOSAGE & ADMINISTRATION

Adults & Children over 12 yrs of age:

tilt head to the side and place 10 drops into the ear canal.

Tip of applicator should not enter into the ear canal

Keep drops in ear for several minutes by keeping head tilted sideways 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 yrs of age:

Consult a physician.

INDICATIONS & USAGE

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

PURPOSE

Earwax Removal Aid

WARNINGS

Warnings

For external use only

Ask a doctor before use if you have:

ear drainage or discharge

ear pain, irritation, or rash in the ear

recently had surgery

dizziness

an injury or perforation (hole) of the eardrum

ACTIVE INGREDIENT

Carbamide Peroxide 6.5%

INACTIVE INGREDIENT

Aloe Barbadensis Leaf Extract

Chamomilla Recutita (Matricaria) Flower Extract

Glycerin

Mineral Oil

Oxyquinoline Sulfate

Purified Water

KEEP OUT OF REACH OF CHILDREN

Keep this and all drugs out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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: 69842-096
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)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-096-45	1 in 1 CARTON	06/05/2019
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 final	part344	06/05/2019

Labeler - CVS Pharmacy (062312574)

Registrant - Humco Holding Group, Inc (825672884)

Establishment
Name	Address	ID/FEI	Business Operations
Humco Holding Group, Inc		825672884	manufacture(69842-096) , analysis(69842-096) , label(69842-096) , pack(69842-096)