EAR DROPS- carbamide peroxide 6.5% liquid

Ear Drops by

Drug Labeling and Warnings

Ear 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]

INACTIVE INGREDIENT

Citric Acid

Flavor

Glycerin

Propylene Glycol

Sodium Lauroyl Sarcosinate

Sodium Stannate

Purified Water

PURPOSE

Earwax removal aid.

DOSAGE & ADMINISTRATION

Adults and children over 12 yrs of age: tilt head to the side and place 5 to 10 drops into the ear canal.

KEEP OUT OF REACH OF CHILDREN

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

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 ear surgery

Dizziness

An injury or perforation (hole) of the eadrum

ACTIVE INGREDIENT

Carbamide Peroxide 6.5%

INDICATIONS & USAGE

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EAR DROPS 
carbamide peroxide 6.5% liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-097
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
WATER (UNII: 059QF0KO0R)
SODIUM STANNATE (UNII: NJ7C1V83KG)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-097-90	1 in 1 CARTON	06/04/2019
1		15 mL in 1 CONTAINER; Type 0: Not a Combination Product
2	NDC: 69842-097-45	1 in 1 CARTON	06/04/2019
2		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	06/04/2019

Labeler - CVS Pharmacy (062312574)

Registrant - Humco Holding Group, Inc (825672884)

Establishment
Name	Address	ID/FEI	Business Operations
Humco Holding Group, Inc		825672884	manufacture(69842-097) , analysis(69842-097) , pack(69842-097) , label(69842-097)