Label: EAR WAX TREATMENT- carbamide peroxide solution/ drops

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 February 9, 2011

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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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