EAR DROPS MAJOR (CARBAMIDE PEROXIDE 6.5%) LIQUID [REMEDYREPACK INC.]

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EAR DROPS MAJOR (CARBAMIDE PEROXIDE 6.5%) LIQUID [REMEDYREPACK INC.]
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NDC 70518-0524-0
Set ID 465f62ef-38d5-4bca-8659-dedcef119ac5
Category HUMAN OTC DRUG LABEL
Packager REMEDYREPACK INC.
Generic Name
Product Class
Product Number
Application Number PART344
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  • Active ingredient                        Purpose

    Carbamide peroxide  6.5%          Earwax removal aid

  • PURPOSE

  • INDICATIONS & USAGE

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

  • Warnings


    Ask doctor before use if you have • ear drainage or discharge • ear pain • irritation or rash in ear • dizziness • an injury or perforation (hole) of the eardrum • recently had ear surgery

    When using this product avoid contact with eyes

    Stop and ask doctor before use if • you need to use for more than four days • excessive earwax remains after use of this product

    Keep out of reach of children

  • DOSAGE & ADMINISTRATION

    DirectionsFor 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 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.

  • INACTIVE INGREDIENT

    Citric Acid, Flavor, Glycerin, Propylene Glycol, Sodium Lauroyl Sarcosinate, Sodium Stannate, Water

  • PRINCIPAL DISPLAY PANEL

    DRUG: Ear DropsMajor Major

    GENERIC: Carbamide Peroxide 6.5%

    DOSAGE: LIQUID

    ADMINSTRATION: AURICULAR (OTIC)

    NDC: 70518-0524-0

    PACKAGING: 15 mL in 1 BOTTLE

    OUTER PACKAGING: 1 in 1 CARTON

    ACTIVE INGREDIENT(S):

    • Carbamide Peroxide 6.5g in 100mL

    INACTIVE INGREDIENT(S):

    • CITRIC ACID MONOHYDRATE
    • Sodium Lauroyl Sarcosinate
    • Sodium Stannate
    • Glycerin
    • Propylene Glycol
    • Water

    Remedy_Label

  • INGREDIENTS AND APPEARANCE
    EAR DROPS  MAJOR
    carbamide peroxide 6.5% liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70518-0524(NDC:0904-6627)
    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
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
    SODIUM STANNATE (UNII: NJ7C1V83KG)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70518-0524-01 in 1 CARTON05/11/2017
    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 finalpart34405/11/2017
    Labeler - REMEDYREPACK INC. (829572556)
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