EAR WAX REMOVING DROPS CARBAMIDE PEROXIDE (PREFERRED PLUS) LIQUID [KINRAY INC]

EAR WAX REMOVING DROPS CARBAMIDE PEROXIDE (PREFERRED PLUS) LIQUID [KINRAY INC]
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NDC 61715-031-74
Set ID 08bf1b45-2a5d-4148-b5bd-f3d9e0244b26
Category HUMAN OTC DRUG LABEL
Packager Kinray Inc
Generic Name
Product Class
Product Number
Application Number PART344
  • ACTIVE INGREDIENT

    Active Ingredient

    Carbamide Peroxide 6.5%

  • PURPOSE

    Purpose

    Softens and Loosens Wax

  • INDICATIONS & USAGE

    Uses

    Safely and gently removes ear wax.

  • WARNINGS

    Warnings

    Do not use: 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: avoid contact with the eyes.

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

  • 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.

  • DOSAGE & ADMINISTRATION

    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 cotton in ear.  Use twice daily for up to four 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.

  • INACTIVE INGREDIENT

    Inactive ingredients

    Glycerin, Oxyquinoline, Aloe Barbadensis Leaf Extract, Anthemis Nobilis Flower Oil

  • PRINCIPAL DISPLAY PANEL

    Ear Wax Removal System

    Carton label



  • INGREDIENTS AND APPEARANCE
    EAR WAX REMOVING DROPS  CARBAMIDE PEROXIDE
    preferred plus liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61715-031
    Route of AdministrationAURICULAR (OTIC)
    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
    GLYCERIN (UNII: PDC6A3C0OX)  
    OXYQUINOLINE (UNII: 5UTX5635HP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61715-031-741 in 1 CARTON
    115 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34403/15/2013
    Labeler - Kinray Inc (012574513)

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