Label: CLEARCANAL EAR WAX SOFTERNER DROPS- carbamide peroxide solution/ drops

  • NDC Code(s): 13709-230-01, 13709-230-10
  • Packager: NeilMed Pharmaceuticals, Inc.
  • Category: HUMAN OTC DRUG LABEL

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.

Drug Label Information

Updated May 7, 2021

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • ACTIVE INGREDIENT

    Drug Facts:

    Active ingredient: CARBAMIDE PEROXIDE


  • Ear Wax Removal Drops Directions

    Step 1 Ear Wax Removal Drops Directions:

    • FOR USE IN THE EAR 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 enclosed ear plugs in ear.
    • Use twice daily for upto 4 days if needed or as directed by a doctor.
    • Any wax remaining after treatment may be removed by gently flushing the ear with NeilMed ClearCanal rinsing system with special ear rinse adapter.
    • Children under 12 years of age: consult a doctor.
  • STORAGE AND HANDLING

    Avoid exposing bottle to excessive heat and direct sunlight. Keep cap on bottle when not in use.

  • INACTIVE INGREDIENT

    Inactive Ingredients: Glycerin, Oxyquinoline, Aloe Barbadensis, Chamomile

  • PURPOSE

    Softens ear wax. Ear wax removal drops

  • ASK DOCTOR

    Children under 12 years of age: consult a doctor.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. If accidental contact with eyes occurs, flush eyes with water and consult a doctor.

  • DO NOT USE

    Do not use:

        * If you have had an allergic reaction to Carbamide Peroxide.
        * If you have ear drainage or discharge, ear pain, irritation or rash in the ear, or are dizzy; consult a doctor
        * If you have an injury or perforation (hole) of the eardrum or after ear surgery, unless directed by a doctor
        * For more than four consecutive days

  • STOP USE

    Stop use ad ask a doctor if excessive ear wax remains after use of this product for four consecutive days

  • WHEN USING

    When using this product:

        * Avoid contact with the eyes

  • DESCRIPTION

    Ear Wax Removal Complete System

    Ear wax is an important part of your body's system for keeping dirt, bacteria and other things from causing hearing problems. When rinsing is necessary, this cleaning system helps to soften, loosen and remove the excessive ear wax.

    The system consists of kit with 1 bottle carbamide peroxide solution 15mL and 1 can sterile saline spray 177mL (or 125mL).


  • DOSAGE & ADMINISTRATION

    Place 5 to 10 drops of 6.5% carbamide peroxide solution into e

  • WARNINGS

    Warnings:
    Do not use:
    If you have had an allergic reaction to carbamide peroxide.
    If you have ear drainage or discharge, ear pain, irritation or rash in the ear, or are dizzy; consult a doctor
    If you have an injury or perforation (hole) of the eardrum or after ear surgery, unless directed by a doctor
    For more than four consecutive days
    When using this product:
    void contact with the eyes
    Stop use ad ask a doctor if excessive ear wax remains after use of this product for four consecutive days.

  • PRINCIPAL DISPLAY PANEL

    1

  • ClearCanal Earwax Removal Kit_Product Label

    NeilMed ClearCanal Earwax Removal Kit

  • INGREDIENTS AND APPEARANCE
    CLEARCANAL EAR WAX SOFTERNER DROPS 
    carbamide peroxide solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13709-230
    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:13709-230-011 in 1 BOX01/02/2012
    115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    2NDC:13709-230-101 in 1 KIT08/24/2012
    215 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34408/24/2011
    Labeler - NeilMed Pharmaceuticals, Inc. (799295915)
    Establishment
    NameAddressID/FEIBusiness Operations
    NeilMed Pharmaceuticals, Inc.799295915manufacture(13709-230)