EAR WAX REMOVAL SYSTEM RITE AID- carbamide peroxide - 6.50% kit

Ear Wax Removal System by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active ingredient                              Purpose

Carbamide Peroxide - 6.50%             Earwax removal aid

Uses

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

PURPOSE

WarningsFor external use only

Keep out of reach of the children

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

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.

Other information

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

Inactive ingredient

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EAR WAX REMOVAL SYSTEM  RITE AID
carbamide peroxide - 6.50% kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11822-1225

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11822-1225-7	1 in 1 KIT	10/07/2011

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE	15 mL

Part 1 of 1

EAR WAX REMOVAL DROPS  RITE AID
carbamide peroxide - 6.50% solution/ drops

Product Information
Item Code (Source)	NDC: 11822-1226
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 VERA LEAF (UNII: ZY81Z83H0X)
CHAMOMILE (UNII: FGL3685T2X)
Glycerin (UNII: PDC6A3C0OX)
Oxyquinoline Sulfate (UNII: 61VUG75Y3P)
Mineral Oil (UNII: T5L8T28FGP)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11822-1226-1	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	10/07/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part344	10/07/2011

Labeler - Rite Aid (014578892)

Registrant - Product Quest Mfg (927768135)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg		927768135	manufacture(11822-1226) , pack(11822-1225)