Label: AURALYT- carbamide peroxide liquid

  • NDC Code(s): 53145-311-04
  • Packager: Menper Distributors, Inc
  • 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 3, 2020

If you are a consumer or patient please visit this version.

  • Active Ingredient

    Carbamide Peroxide 6.5%...........Earwax removal aid

  • Purpose

    Earwax removal aid

  • Uses

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

  • AVOID CONTACT WITH EYES

    Do not use :

    • if you have ear drainage or discharge, ear pain, irritation, or rash in the ear or are dizzy, consult a doctor 
    • if you have an injury or perforation (hole) of the ear drum or after ear surgery unless directed by a doctor
    • for more than 4 days; if excessive ear wax remains after use of this product, consult a doctor.
  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of children.

  • if pregnate or breast-feeding

    ask a health professional before use.

    In case of accidental indegestion, 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 wax remaining after treatment may be removed by gently flushing the ear with warm water, using soft ruber bulb ear syringe.
    • Children under 12 years of age: consult a doctor.

  • Other information

    Store this product between 15° to 30° C (59°-86° F)
    Tamper-Evident Feature: Do not use this product if imprinted safety seal over bottle cap is torn, broken, or missing

  • Inactive ingredients

    Cajeput oil, camphor, eucalyptus oil, glycerin, menthol, methlyparaben, phosphoric acid, polysorbate 20, propylene glycol, sodium stannate, water

  • Questions or comments?

    1-800-560-5223 M-F from 9 AM to 4 PM  Eastern.

  • PRINCIPAL DISPLAY PANEL

    AuralytAuralyt

  • INGREDIENTS AND APPEARANCE
    AURALYT 
    carbamide peroxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53145-311
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) CARBAMIDE PEROXIDE7.8 mg  in 12 mL
    Inactive Ingredients
    Ingredient NameStrength
    CAJUPUT OIL (UNII: J3TO6BUQ37)  
    CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MENTHOL (UNII: L7T10EIP3A)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM STANNATE (UNII: NJ7C1V83KG)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53145-311-041 in 1 CARTON01/01/2014
    112 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 finalpart34401/01/2014
    Labeler - Menper Distributors, Inc (101947166)