EAR DROPS MAJOR- carbamide peroxide 6.5% liquid

Ear Drops by

Drug Labeling and Warnings

Ear Drops by is a Otc medication manufactured, distributed, or labeled by Major Pharmaceuticals, Pharma Nobis, 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 doctor before use if you have ear drainage or discharge ear pain irritation or rash in ear dizziness an injury or perforation (hole) of the eardrum recently had ear surgery

When using this product avoid contact with eyes

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

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 the children
If product is swallowed, get medical help or contact a Poison Control Center right away

DOSAGE & ADMINISTRATION

Directions- For use in the ear 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

Citric Acid, Flavor, Glycerin, Propylene Glycol, Sodium Lauroyl Sarcosinate, Sodium Stannate, Water

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact a Poison Control Center right away.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EAR DROPS  MAJOR
carbamide peroxide 6.5% liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0904-6627
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	6.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM STANNATE (UNII: NJ7C1V83KG)
GLYCERIN (UNII: PDC6A3C0OX)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0904-6627-35	1 in 1 CARTON	10/10/2019
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 final	part344	10/10/2019

Labeler - Major Pharmaceuticals (191427277)

Registrant - Humco Holding Group, Inc. (825672844)

Establishment
Name	Address	ID/FEI	Business Operations
Humco Holding Group, Inc.		825672884	analysis(0904-6627) , manufacture(0904-6627) , pack(0904-6627) , label(0904-6627)