EARWAX REMOVAL DROPS- carbamide peroxide 6.5% liquid 
Randob Labs, Ltd.

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ERO Earwax Removal Kit

FOR USE IN THE EAR ONLY

Adults & Children over 12 yrs of age:

Tilt head to the side and place 5-10 drops into ear.

Dropper tip of removal drops 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 four days if needed, or as directed by a doctor.

Safely scoop out wax with removal tool.

Any wax remaining after treatment may be removed by gently flushing the ear with warm water, using the ear bulb syringe.

Children under 12 yrs of age:

Consult a doctor.

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

Earwax Removal Aid

Carbamide Peroxide 6.5%

Aloe Barbadensis Leaf Extract

Chamomilla Recutita (Matricaria) Flower Extract

Glycerin

Mineral Oil

Oxyquinoline Sulfate

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1212) right away.

When using this product avoid contact with eyes.

Stop use and ask a doctor if:

you need to use more than four days

excessive earwax remains after use of this product

Other Information

Do not use if neck wrap imprinted safety seal is broken or missing

Do not store above 25 degrees C, 77 degrees F

Store bottle in outer carton

Keep cap on bottle when not in use

Product foams on contacy with earwax due to release of oxygen

Warnings

Ask a doctor before use if you have:

ear drainage or discharge

ear pain

irritation, or rash in the ear

dizziness

an injury or perforation (hole) of the eardrum

recently had ear surgery

ERO Label.jpgERO IFC.jpg

EARWAX REMOVAL DROPS 
carbamide peroxide 6.5% liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52412-600
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52412-600-051 in 1 CARTON07/03/2020
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 DrugM01407/03/2020
Labeler - Randob Labs, Ltd. (061995007)
Registrant - Pharma Nobis, LLC (118564114)
Establishment
NameAddressID/FEIBusiness Operations
Pharma Nobis, LLC118564114manufacture(52412-600) , analysis(52412-600) , label(52412-600) , pack(52412-600)

Revised: 12/2023
Document Id: 0ce5bdec-f500-73d9-e063-6294a90a6a87
Set id: a9904b63-27a4-205c-e053-2995a90af762
Version: 4
Effective Time: 20231219
 
Randob Labs, Ltd.