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 REMEDYREPACK INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient                        Purpose

Carbamide peroxide  6.5%          Earwax removal aid

PURPOSE

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

Keep out of reach of children

DOSAGE & ADMINISTRATION

DirectionsFor 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

PRINCIPAL DISPLAY PANEL

DRUG: Ear DropsMajor Major

GENERIC: Carbamide Peroxide 6.5%

DOSAGE: LIQUID

ADMINSTRATION: AURICULAR (OTIC)

NDC: 70518-0524-0

PACKAGING: 15 mL in 1 BOTTLE

OUTER PACKAGING: 1 in 1 CARTON

ACTIVE INGREDIENT(S):

• Carbamide Peroxide 6.5g in 100mL

INACTIVE INGREDIENT(S):

• CITRIC ACID MONOHYDRATE
• Sodium Lauroyl Sarcosinate
• Sodium Stannate
• Glycerin
• Propylene Glycol
• Water

INGREDIENTS AND APPEARANCE

EAR DROPS  MAJOR
carbamide peroxide 6.5% liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70518-0524(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
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
SODIUM STANNATE (UNII: NJ7C1V83KG)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70518-0524-0	1 in 1 CARTON	05/11/2017
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	05/11/2017

Labeler - REMEDYREPACK INC. (829572556)