Active ingredient Purpose

Carbamide peroxide 6.5% Earwax removal aid

Uses

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 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

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.

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

Rite Aid Earwax Kit

Rite Aid Earwax Kit 2022 Rite Aid Earwax Kit.jpg

EARWAX REMOVAL KIT RITE AID
carbamide peroxide 6.5% kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11822-1222

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:11822-1222-7	1 in 1 KIT; Type 0: Not a Combination Product	10/04/2011

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

Part 1 of 1

EAR WAX RMVL RITE AID
carbamide peroxide 6.5% liquid

Product Information
Route of Administration	AURICULAR (OTIC)

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	CARBAMIDE PEROXIDE	6.5 g in 100 mL

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:11822-1224-1	15 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M014	10/04/2011

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M014	10/04/2011

Labeler - Rite Aid (014578892)

Registrant - Pharma Nobis, LLC (118564114)

Name	Address	ID/FEI	Business Operations
Establishment
Pharma Nobis, LLC		118564114	manufacture(11822-1222) , label(11822-1222)