Label: EAR WAX REMOVAL DROPS- carbamide peroxide - 6.5% 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 March 2, 2020

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  • Active ingredient

    Carbamide Peroxide, 6.5%

  • PURPOSE

    Earwax removal aid

  • Uses

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

  • Warnings

    Do not use if you have 

    •
    eardrainage, discharge, ear pain,irritation
    •
    rashin the ear,or are dizzy
    •
    injuryor perforation (hole) of the ear drum or after ear surgery
  • When using this product 

    •
    do not use for more than four days
    •
    avoid contact with the eyes. If accidental contact with the eyes occurs, flush eyes with water and consult a doctor
    •
    if excessive earwax remains after the use of this product, consult a doctor
  • Keep out of the 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 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 earwax remaining after treatment may be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe.
    •
    When the ear canal is irrigated, the tip of the ear syringe should not obstruct the flow of water leaving the ear canal.
    •
    Children under 12 years:  consult a doctor.
  • Other information

    •
    Protect from heat and direct sunlight 
    •
    Keep cap on bottle when not in use.
    •
    Lot No. and EXP date:  see label, bottom container or box.
     
    NDC 68788-7496-01 1 Bottle .5FL OZ

    Relabeled by Preferred Pharmaceuticals, Inc.

  • Inactive ingredients

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

  • Principal Display Panel Bottle Label 0.5 FL OZ

    Ear Drops

    Preferred Plus Pharmacy

    Ear Wax Removal drops 

    Carbamide Peroxide 6.5%

    0.5 FL OZ (15ml)

     
    NDC: 68788-7498-01 Bottle .5 FL OZ

    Relabeled by Preferred Pharmaceuticals, Inc.

  • INGREDIENTS AND APPEARANCE
    EAR WAX REMOVAL DROPS 
    carbamide peroxide - 6.5% solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-7498(NDC:57896-339)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) CARBAMIDE PEROXIDE65 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TARTARIC ACID (UNII: W4888I119H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68788-7498-11 in 1 CARTON03/02/2020
    115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34403/02/2020
    Labeler - Preferred Pharmaceuticals, Inc. (791119022)
    Registrant - Preferred Pharmaceuticals, Inc. (791119022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Preferred Pharmaceuticals, Inc.791119022RELABEL(68788-7498)
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