ERO EAR WAX REMOVAL KIT- carbamide peroxide 6.5% liquid 
Randob Labs

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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ERO Ear Wax Removal Kit

Carbamide Peroxide 6.5%

Earwax removal aid

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

Ask a doctor before use if you have

When using this product avoid contact with the 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.

If product is swallowed, get medical help or contact a Poison Control Center right away.

FOR IN EAR USE 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.

Aloe Barbadensis Extract, Chamomilla Recutita (Matricaria) Flower Extract, Citric Acid, Glycerin, Propylene Glycol, Sodium Citrate, Sodium Lauryl Sulfate, Tartaric Acid.

Carton

ERO EAR WAX REMOVAL KIT 
carbamide peroxide 6.5% liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52412-175
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) CARBAMIDE PEROXIDE6.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CHAMOMILE (UNII: FGL3685T2X)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
TARTARIC ACID (UNII: W4888I119H)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52412-175-011 in 1 CARTON04/16/2021
115 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM01404/16/2021
Labeler - Randob Labs (061995007)
Registrant - Derma Care Research Labs, LLC (116817470)
Establishment
NameAddressID/FEIBusiness Operations
Derma Care Research Labs, LLC116817470manufacture(52412-175)

Revised: 5/2023
Document Id: fbf8a6f2-531c-5047-e053-6294a90aaa01
Set id: fbf8a6f2-531d-5047-e053-6294a90aaa01
Version: 1
Effective Time: 20230518
 
Randob Labs