Citric Acid

Flavor

Glycerin

Propylene Glycol

Sodium Lauroyl Sarcosinate

Sodium Stannate

Purified Water

Earwax removal aid.

Adults and children over 12 yrs of age: tilt head to the side and place 5 to 10 drops into the ear canal.

Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

For External Use Only.

Ask a doctor before use if you have:

Ear drainage or discharge

Ear pain, irritation, or rash in the ear

Recently had ear surgery

Dizziness

An injury or perforation (hole) of the eadrum

Carbamide Peroxide 6.5%

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

CVS Label

carton

Leader Label

Leader2022

Rite Aid Earwax Kit 2022

EARWAX REMOVAL DROPS
carbamide peroxide 6.5% liquid

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	CARBAMIDE PEROXIDE	0.065 mg in 1 mL

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0395-9133-90	1 in 1 CARTON	06/04/2019
1		15 mL in 1 CONTAINER; Type 0: Not a Combination Product
2	NDC:0395-9133-45	1 in 1 CARTON	06/04/2019
2		15 mL in 1 BOTTLE, DROPPER; 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	06/04/2019

Labeler - Humco Holding Group, Inc (825672884)

Registrant - Pharma Nobis, LLC (118564114)

Name	Address	ID/FEI	Business Operations
Establishment
Pharma Nobis, LLC		118564114	manufacture(0395-9133) , analysis(0395-9133) , pack(0395-9133) , label(0395-9133)