EAR WAX REMOVAL DROPS- carbamide peroxide liquid

Ear Wax Removal Drops by

Drug Labeling and Warnings

Ear Wax Removal Drops by is a Otc medication manufactured, distributed, or labeled by Product Quest Mfg. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient                                           Purpose
Carbamide Peroxide 6.5%............................Earwax removal aid

PURPOSE

INDICATIONS & USAGE

Uses

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

WARNINGS

Warnings
Do not use if you have ear drainage or discharge, ear pain,
irritation or rash in the ear, or are dizzy; consult a doctor. if
you have an injury or perforation (hole) of the ear drum or after
ear surgery unless directed by a doctor. for more than four
consecutive days.
When using this product avoid contact with eyes
Stop use and ask a doctor if excessive ear wax remains
after use of this product for four consecutive days

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or
contact a Poison Control Center right away. If accidental contact
with eyes occurs, flush eyes with water and consult a doctor.

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 ear. Use twice daily for up to four 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

OTHER SAFETY INFORMATION

Other information

Protect from heat and direct sunlight.
Keep cap on bottle when not in use

INACTIVE INGREDIENT

Inactive ingredients

Aloe Barbadensis Leaf Extract,
Chamomilla Recutita (Matricaria) Flower Extract, Glycerin,
Mineral Oil, Oxyquinoline Sulfate, Water.

Questions? 866-483-2846

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EAR WAX REMOVAL DROPS 
carbamide peroxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64048-5118
Route of Administration	TOPICAL

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
Aloe (UNII: V5VD430YW9)
CHAMOMILE (UNII: FGL3685T2X)
Glycerin (UNII: PDC6A3C0OX)
Mineral Oil (UNII: T5L8T28FGP)
Oxyquinoline Sulfate (UNII: 61VUG75Y3P)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64048-5118-1	1 in 1 CARTON	10/05/2011
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	10/05/2011

Labeler - Product Quest Mfg (927768135)

Registrant - Product Quest Mfg (927768135)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg		927768135	manufacture(64048-5118) , label(64048-5118)