EAR DROPS EARWAX REMOVAL AID- carbamide peroxide liquid

Ear Drops by

Drug Labeling and Warnings

Ear Drops by is a Otc medication manufactured, distributed, or labeled by AmerisourceBergen Drug Corporation (Good Neighbor Pharmacy), Lee Pharmaceuticals, AmerisourceBergen Drug Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Carbamide Peroxide, 6.5%

Purpose

Earwax removal aid

Uses

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

Warnings

ASK DOCTOR

Ask a doctor before use if you have

• ear drainage or discharge
• ear pain
• irritation or rash in the ear
• dizziness
• and injury or perforation (hole) of the ear drum
• recently had ear surgery

Stop use and ask a doctor if

• you need to use of r more than 4 days
• excessive ear wax remains after use of this product

WHEN USING

When using this product do not get into eyes

Keep out of reach of children

In case of accidental overdose or allergic reaction, get medical help or contact a Poison Control Center immediately

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:  consult a doctor.

Other information

• Avoid exposing bottle to excessive heat and direct sunlight.
• Product foams on contact with earwax due to release of oxygen.  There may be an associated crackling.
• Keep cap on bottle when not in use.
• Lot no. and exp. date:  see label, bottom container or box.

Inactive ingredients

Anhydrous Glycerin, Citric Acid, Propylene Glycol, Sodium Citrate, Sodium Lauryl Sulfate, Tartaric Acid

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EAR DROPS  EARWAX REMOVAL AID
carbamide peroxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24385-955
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	CARBAMIDE PEROXIDE	65 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TARTARIC ACID (UNII: W4888I119H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24385-955-01	1 in 1 CARTON
1	NDC: 24385-955-02	15 mL in 1 BOTTLE, DROPPER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part344	01/01/2012

Labeler - AmerisourceBergen Drug Corporation (Good Neighbor Pharmacy) (007914906)

Registrant - Lee Pharmaceuticals (056425432)

Establishment
Name	Address	ID/FEI	Business Operations
AmerisourceBergen Drug Corporation		007914906	label(24385-955)

Establishment
Name	Address	ID/FEI	Business Operations
Lee Pharmaceuticals		056425432	manufacture(24385-955)