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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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.

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EARWAX REMOVAL DROPS 
carbamide peroxide 6.5% liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0395-9132
Route of AdministrationAURICULAR (OTIC)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) CARBAMIDE PEROXIDE0.065 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CHAMOMILE (UNII: FGL3685T2X)  
OXYQUINOLINE SULFATE (UNII: 61VUG75Y3P)  
MINERAL OIL (UNII: T5L8T28FGP)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0395-9132-451 in 1 CARTON06/05/2019
115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34406/05/2019
Labeler - Humco Holding Group, Inc (825672884)
Registrant - Pharma Nobis, LLC (118564114)
Establishment
NameAddressID/FEIBusiness Operations
Pharma Nobis, LLC118564114manufacture(0395-9132) , analysis(0395-9132) , label(0395-9132) , pack(0395-9132)

Revised: 3/2022
Document Id: da6ccb2c-0fd1-5e34-e053-2a95a90a509e
Set id: a8bfdc6d-5679-432a-e053-2995a90ad380
Version: 2
Effective Time: 20220317
 
Humco Holding Group, Inc