HARRIS TEETER EARWAX REMOVAL DROPS- carbamide peroxide 6.5% liquid 
Harris Teeter LLC

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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Carbamide Peroxide 6.5%

Earwax removal aid

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

Do not use

When using this product avoid contact with the eyes. If accidental contact with the eyes occurs, flush your eyes with water and consult a doctor.

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.

Citric acid, glycerin, propylene glycol, sodium citrate, sodium lauryl sulfate, tartaric acid.

Carton

HARRIS TEETER EARWAX REMOVAL DROPS 
carbamide peroxide 6.5% liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69256-117
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
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
TARTARIC ACID (UNII: W4888I119H)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69256-117-011 in 1 CARTON04/27/2022
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 finalpart34404/27/2022
Labeler - Harris Teeter LLC (048463103)
Registrant - Derma Care Research Labs, LLC (116817470)
Establishment
NameAddressID/FEIBusiness Operations
Derma Care Research Labs, LLC116817470manufacture(69256-117)

Revised: 4/2022
Document Id: dda4c4bf-425f-4fff-e053-2a95a90a51bc
Set id: dda4c4bf-425e-4fff-e053-2a95a90a51bc
Version: 1
Effective Time: 20220427
 
Harris Teeter LLC