NEILMED CLEAR CANAL EARWAX REMOVAL KIT- carbamide peroxide solution/ drops 
NEILMED PHARMACEUTICALS INC

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NeilMed ClearCanal EarWax Removal Complete Kit (BKC)

Drug Facts

Active Ingredients

Carbamide Peroxide 6.5%

Purpose

Earwax Softener

Uses

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

! Warnings

Avoid using the product and ask a doctor before use if you have :

To prevent contamination, do not share this product with others.

When using this product:

Avoid contact with the eyes. If accidental contact occurs, flush eyes with water and consult a doctor.

Stop use and ask a doctor if:

Keep this and all drugs out of the reach of children

Children under 12 years should not use this product.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions
FOR USE IN THE EAR ONLY

Adults and children over 12 years of age:

Other Information:

Recommended storage conditions:

Inactive Ingredients

Glycerin, Oxyquinoline

Ingredients for ClearCanal® Saline Spray :

Contents :

1 can saline spray 75ml (2.53 fl oz), 1 bottle of ear drops 15ml (0.5 fl oz), 1 drainage collection cup, 2 ear plugs, 1 waxout tool and 1 soft silicone ear syringe. Colors of parts may vary.

Directions:

This product is intended for use on adults and children over 12 years of age. Consult your physician for use on children under 12.

Tilt head sideways and place 10 drops of ClearCanal Carbamide peroxide into each ear canal by squeezing the plastic dropper bottle provided with this system. The tip of bottle should not enter ear canal.

Keep drops in ear for 10 minutes by head tilted or placing enclosed ear plugs in ears. It is normal to feel warmth in ear due to carbamide peroxide. Remove ear plugs. Attach the special drainage collection cup to the canister to avoid the rinse solution dripping out of your ear. Flush ears with the NeilMed ClearCanal specially designed actuator nozzle for 10 seconds or as desired to achieve adequate flushing. Gently tilt head side to side to drain out residual liquid and dry ears with a clean dry towel wrapped on a finger.

ClearCanal Earwax Removal Complete Kit

NeilMed ClearCanal Earwax Removal Kit

ClearCanal Earwax Removal Saline Spray

Clearcanal earwax Removal saline spray

NEILMED CLEAR CANAL EARWAX REMOVAL KIT 
carbamide peroxide solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13709-314
Route of AdministrationAURICULAR (OTIC)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) CARBAMIDE PEROXIDE65 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
OXYQUINOLINE (UNII: 5UTX5635HP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13709-314-011 in 1 KIT12/25/2021
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 DrugM01412/25/2021
Labeler - NEILMED PHARMACEUTICALS INC (799295915)
Establishment
NameAddressID/FEIBusiness Operations
NEILMED PHARMACEUTICALS INC799295915manufacture(13709-314)

Revised: 1/2024
Document Id: 0eb0d3b3-1a54-1c93-e063-6294a90a6d13
Set id: d330552d-07b6-f01e-e053-2a95a90a7ca5
Version: 2
Effective Time: 20240111
 
NEILMED PHARMACEUTICALS INC