Label: WAXRX EAR WAX REMOVAL AID DROPS- carbamide peroxide liquid

  • NDC Code(s): 72724-001-15
  • Packager: DOCTOR EASY MEDICAL PRODUCTS, LLC
  • 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 December 12, 2018

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  • ACTIVE INGREDIENT

    Carbamide Peroxide 6.5%

  • PURPOSE

    Carbamide Peroxide 6.5%...................Earwax Removal Aid

  • INDICATIONS & USAGE

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

  • WARNINGS

    Ask a doctor before use if you have
    • ear drainage or discharge

    • ear pain

    • irritation or rash in the ear
    • dizziness

    • an injury or perforation (hole) of the ear drum
    • recently had ear surgery

  • STOP USE

    Stop use and ask a doctor if
    • you need to use for more than 4 days
    • excessive ear wax remains after use of this product

  • WHEN USING

    When using this product do not get into eyes

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of accidental overdose or allergic
    reaction, get medical help or contact a Posion Control Center immediately

  • FOR USE IN THE EAR ONLY

    Adults and children over 12 years of age. Tilt head sideways and place 5-10 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 ears. Flush ear with VERY WARM (body temperature) water using the Wax-Rx Ear Washer.

    Children under 12, consult a physician. Drops my be used twice daily for up to 4 days or as directed by a physician.

  • STORAGE AND HANDLING

    • Avoid exposing bottle to excessive heat or direct sunlight.
    • Product foams on contact with ear wax due to release of oxygen. There may be an associated crackling

    • Keep cap on bottle when not in use.
    • Lot no. and exp. date:see Label, bottom contained or box.

  • INACTIVE INGREDIENT

    Citric Acid, Glycerin, Propylene Glycol, Sodium Citrate, Sodium Lauryl Sulfate, Tartaric Acid

  • PRINCIPAL DISPLAY PANEL

    WaxRx

    EAR WAX

    REMOVAL

    AID DROPS

    6.5% Carbamide Peroxide

    Safe, Fast Acting

    Alcohol Free

    0.5 FL OZ (15 ML)

    WaxRx Drops

  • INGREDIENTS AND APPEARANCE
    WAXRX EAR WAX REMOVAL AID DROPS 
    carbamide peroxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72724-001
    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
    TARTARIC ACID (UNII: W4888I119H)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72724-001-1515 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product12/12/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34412/12/2018
    Labeler - DOCTOR EASY MEDICAL PRODUCTS, LLC (848752523)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sheffield Pharmaceuticals LLC151177797manufacture(72724-001)
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