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Ear Wax Treatment (Rebel Distributors Corp)

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SOLUTION/ DROPS 15 mL in 1 BOTTLE (21695-334-15) Label Information

Complete Ear Wax Treatment Information

  • 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 Type HUMAN OTC DRUG Item Code (Source) NDC:21695-334(NDC:0536-3000)
    Route of Administration AURICULAR (OTIC)
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Carbamide Peroxide (UNII: 31PZ2VAU81) (Carbamide Peroxide - UNII:31PZ2VAU81) Carbamide Peroxide 81.86 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    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
    Color YELLOW (Colorless to pale yellow) Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:21695-334-15 15 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part344 10/26/2009
    Labeler - Rebel Distributors Corp (118802834)
    Establishment
    Name Address ID/FEI Business Operations
    Rebel Distributors Corp 118802834 RELABEL, REPACK