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 Humco Holding Group, Inc, 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.

CVS Label

Leader Label

Rite Aid Label

Major Label

INGREDIENTS AND APPEARANCE

EARWAX REMOVAL DROPS 
carbamide peroxide 6.5% liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0395-9133
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: 0395-9133-90	1 in 1 CARTON	06/04/2019
1		15 mL in 1 CONTAINER; Type 0: Not a Combination Product
2	NDC: 0395-9133-45	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 Drug	M014	06/04/2019

Labeler - Humco Holding Group, Inc (825672884)

Registrant - Pharma Nobis, LLC (118564114)

Establishment
Name	Address	ID/FEI	Business Operations
Pharma Nobis, LLC		118564114	manufacture(0395-9133) , analysis(0395-9133) , pack(0395-9133) , label(0395-9133)