EAR WAX TREATMENT (CARBAMIDE PEROXIDE) SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]

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EAR WAX TREATMENT (CARBAMIDE PEROXIDE) SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]
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NDC 21695-334-15
Set ID 22b7f3d7-7f3e-437f-9326-3eef737edfbb
Category HUMAN OTC DRUG LABEL
Packager Rebel Distributors Corp
Generic Name
Product Class
Product Number
Application Number PART344
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Carbamide peroxide 6.5%

  • Purpose

    Earwax removal aid

  • Use

    softens, loosens and removes excessive earwax

  • Warnings

    Do not use for more than 4 days

    Ask a doctor before use if you have

    • ear drainage or discharge
    • ear pain, irritation, rash or are dizzy
    • an injury or perforation (hole) of the eardrum or if you had ear surgery

    When using this product avoid contact with the eyes

    Stop use and ask a doctor if earwax remains longer than 4 days

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

  • Directions

    FOR USE IN THE EAR ONLY

    adults and children over 12 years:

    • 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 tilting head or placing cotton in ear
    • use twice daily for up to 4 days
    • remove any wax remaining after treatment by gently flushing ear with warm water using a soft rubber bulb ear syringe

    children under 12 years: ask a doctor

  • Other information

    • store at room temperature 15° - 30°C (59° - 89°F)
    • keep in a dry place
  • Inactive ingredients

    citric acid (anhydrous), glycerin, propylene glycol, purified water, sodium acid pyrophosphate, sodium citrate (anhydrous), trolamine

  • Questions or comments?

    Call 1-800-645-2158
    9am - 5pm ET
    Monday - Friday

    Repackaged by:

    Rebel Distributors Corp

    Thousand Oaks, CA 91320

  • PRINCIPAL DISPLAY PANEL - 15 mL Carton

    COMPARE TO
    ACTIVE INGREDIENT IN
    DEBROX®*

    Rugby®
    NDC 21695-334-15

    Earwax
    Treatment
    Drops

    Carbamide Peroxide 6.5 %

    Helps Remove
    Excessive Earwax

    1/2 fl oz (15 mL)

    SATISFACTION GUARANTEED
    Rugby
    OR YOUR MONEY BACK

    Ear Treatment 6.5%

  • INGREDIENTS AND APPEARANCE
    EAR WAX TREATMENT 
    carbamide peroxide solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21695-334(NDC:0536-3000)
    Route of AdministrationAURICULAR (OTIC)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Carbamide Peroxide (UNII: 31PZ2VAU81) (Carbamide Peroxide - UNII:31PZ2VAU81) Carbamide Peroxide81.86 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Glycerin (UNII: PDC6A3C0OX)  
    Sodium Acid Pyrophosphate (UNII: H5WVD9LZUD)  
    Sodium Citrate (UNII: 1Q73Q2JULR)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Trolamine (UNII: 9O3K93S3TK)  
    Product Characteristics
    ColorYELLOW (Colorless to pale yellow) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21695-334-1515 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34410/26/2009
    Labeler - Rebel Distributors Corp (118802834)
    Establishment
    NameAddressID/FEIBusiness Operations
    Rebel Distributors Corp118802834RELABEL, REPACK
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