Label: ENT ESSENTIALS EAR WAX REMVOER- carbamide peroxide liquid

  • NDC Code(s): 68093-4503-1
  • Packager: Wisconsin Pharmacal Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 November 8, 2017

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  • ACTIVE INGREDIENT

    Active Ingredient

    Carbamide Peroxide 6.5%

  • PURPOSE

    Purpose

    Earwax removal aid

  • INDICATIONS & USAGE

    Uses

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

  • WARNINGS

    Warnings

  • ASK DOCTOR

    Aska 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 eardrum
    • recently had ear surgery
  • WHEN USING

    When using this product avoid contact wtih the eyes

  • STOP USE

    Stop use and aks a doctor if

    • you need to use for more than four days
    • excessive earwax remains after use of this product
  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    D irections

    FOR USE IN THE EAR ONLY Adults and children over 12 years of age:

    tilt head sideways
    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 four days if needed, or as directed by a doctor
    any wax remaining after treatment may be removed by gently flusing the ear with warm water, using a soft rubber bulb ear syringe.

    Children under 12 years: consult a doctor.

  • OTHER SAFETY INFORMATION

    Other informaiton

    • store bottle in teh outer carton
    • product foams on contact with earwax due to the release of oxygen. Theremay be an associated "crackling" sound
    • keep cap on bottle when not in use
  • INACTIVE INGREDIENT

    Inactive ingredients

    Glycerin, Polysorbate 20, Propylene glycol, Sodium citrate, Tartaric acid

  • QUESTIONS

    Questions or comments? 1-800-635-3696

  • PRINCIPAL DISPLAY PANEL

    Label and Carton

  • INGREDIENTS AND APPEARANCE
    ENT ESSENTIALS EAR WAX REMVOER 
    carbamide peroxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68093-4503
    Route of AdministrationAURICULAR (OTIC)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) CARBAMIDE PEROXIDE0.065 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    TARTARIC ACID (UNII: W4888I119H)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68093-4503-11 in 1 CARTON02/01/2017
    122 g in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35602/01/2017
    Labeler - Wisconsin Pharmacal Company (800873986)
    Establishment
    NameAddressID/FEIBusiness Operations
    Wisconsin Pharmacal Company800873986manufacture(68093-4503)
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