Private Label Earwax Removal- 0096

Earwax Removal Drops by

Drug Labeling and Warnings

Earwax Removal Drops by is a Otc medication manufactured, distributed, or labeled by Humco Holding Group, Inc, Pharma Nobis, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

EARWAX REMOVAL DROPS- carbamide peroxide 6.5% liquid 
Humco Holding Group, Inc

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Private Label Earwax Removal- 0096

Adults & Children over 12 yrs of age:

tilt head to the side and place 10 drops into the ear canal.

Tip of applicator should not enter into the ear canal

Keep drops in ear for several minutes by keeping head tilted sideways 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 yrs of age:

Consult a physician.

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

Earwax Removal Aid

Warnings

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 surgery

dizziness

an injury or perforation (hole) of the eardrum

Carbamide Peroxide 6.5%

Aloe Barbadensis Leaf Extract

Chamomilla Recutita (Matricaria) Flower Extract

Glycerin

Mineral Oil

Oxyquinoline Sulfate

Purified Water

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

EARWAX REMOVAL DROPS 
carbamide peroxide 6.5% liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0395-9132
Route of Administration	AURICULAR (OTIC)

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

Inactive Ingredients
Ingredient Name	Strength
CHAMOMILE (UNII: FGL3685T2X)
OXYQUINOLINE SULFATE (UNII: 61VUG75Y3P)
MINERAL OIL (UNII: T5L8T28FGP)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0395-9132-45	1 in 1 CARTON	06/05/2019	05/31/2024
1		15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M014	06/05/2019	05/31/2024

Labeler - Humco Holding Group, Inc (825672884)

Registrant - Pharma Nobis, LLC (118564114)

Establishment
Name	Address	ID/FEI	Business Operations
Pharma Nobis, LLC		118564114	manufacture(0395-9132) , analysis(0395-9132) , label(0395-9132) , pack(0395-9132)

Revised: 12/2023

Document Id: 0d99ad33-6033-1d16-e063-6294a90a1ee2

34390-5

Set id: a8bfdc6d-5679-432a-e053-2995a90ad380

Version: 3

Effective Time: 20231228