EAR WAX REMOVER (CARBAMIDE PEROXIDE) LIQUID [PROFICIENT RX LP]

EAR WAX REMOVER (CARBAMIDE PEROXIDE) LIQUID [PROFICIENT RX LP]
PDF | XML

NDC 63187-187-15
Set ID cd054ea1-2bfa-4814-bd88-618c4b8f04b5
Category HUMAN OTC DRUG LABEL
Packager Proficient Rx LP
Generic Name
Product Class
Product Number
Application Number PART344
  • Active Ingredient



    Active ingredient                                    Purpose

    Carbamide Peroxide 6.5%..........................Earwax Removal Aid


  • Uses



    Uses for occasional use as an aid to soften, loosen and remove excessive ear wax.

  • 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.

  • Indications and Usage


    Uses for occasional use as an aid to soften, loosen and remove excessive ear wax.

  • Warnings

    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 ear drum
    - recently had ear surgery

    Stop use and ask a doctor if
    - you need to use for more than four days
    - excessive wax remains after use of this product

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

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

  • Directions

    Directions
    FOR USE IN THE EAR ONLY


    Unscrew cap from bottle. Remove foil safety seal from bottle. Affix applicator cap to bottle.

    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 ear syringe.
    - when the ear canal is irrigated, the tip of the ear syringe should not obstruct the flow of water leaving the ear canal

    Children under 12 years of age: consult a doctor.

    Other information
    - avoid exposing the bottle to excessive heat and direct sunlight
    - keep cap on bottle when not in use
    - lot no. & exp date: see label, bottom of container or box
    - retain carton for future reference on full labeling
    - Note: Drops foam on contact with ear wax due to release of oxygen. There may be an associated "cracking" sound
    - Note: Oversize packaging for ease in reading label information. Contains one bottle.
    - Store between 20 degrees to 25 degrees C (68 degrees to 77 degrees F)

  • Inactive Ingredients



    Inactive ingredients

    anhydrous glycerin, citric acid, propylene glycol, sodium lauryl sulfate, sodium citrate, tartaric acid

  • Questions?

     Adverse Drug Event Call toll free: (800) 616-2471

  • Principal Display Panel

    NDC 63187-187-15

    EAR WAX REMOVER
    WITH IRRIGATOR
    Earwax Removal Aid
    (carbamide peroxide 6.5%)

    Distributed by:

    MAJOR PHARMACEUTICALS
    31778 Enterprise Drive
    Livonia, MI 48150  USA

    Relabeled By:

    Proficient Rx LP

    Thousand Oaks, CA 91320

    63187-187-15
  • INGREDIENTS AND APPEARANCE
    EAR WAX REMOVER 
    carbamide peroxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63187-187(NDC:0904-6004)
    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
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    GLYCERYL 1-DIACETYLTARTRATE 2,3-DISTEARATE (UNII: M25488413L)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63187-187-151 in 1 CARTON01/01/2019
    115 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34405/27/2009
    Labeler - Proficient Rx LP (079196022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Proficient Rx LP079196022REPACK(63187-187) , RELABEL(63187-187)

Related Drugs