Label: TILCARE- carbamide peroxide 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 January 25, 2021

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  • Drug Facts

  • Active ingredient

    Carbamide peroxide 6.5%

  • Purpose

    Earwax removal aid

  • Use

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

  • Warnings

    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 four days.

    When using this product avoid contact with the eyes.

    Stop use and ask a doctor if excessive earwax remains after use of this product.

    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 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 a soft rubber bulb ear syringe.

    • children under 12 years of age: consult a doctor.

  • Other information

    • tamper evident: Do not use if outer carton is open, torn or missing.

    • store bottle in the outer carton and keep the tip on bottle when not in use

    • store at 20-25°C (68-77°F)

    • drops foam in contact with earwax due to release of oxygen. You may experience a “crackling” sound

  • Inactive ingredients

    Glycerin, Lauroyl Sarcosine, Propylene Glycol

  • Questions?

    +1-844-324-5669

    You may also report serious side effects to this phone number.

  • SPL UNCLASSIFIED SECTION

    Gently Removes Excessive Earwax

    Safe & Easy to Use

    Dist. by: Tilco Trading PTE. LTD. 491B River Valley Road #15-01, Valley Point, Singapore - 248373
    Made in USA
    www.tilcare.com / customers@tilcare.com

    Carbamide peroxide 6.5%

  • Packaging

    Ear drops

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    TILCARE 
    carbamide peroxide solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73390-101
    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
    GLYCERIN (UNII: PDC6A3C0OX)  
    LAUROYL SARCOSINE (UNII: LIJ19P3L6F)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73390-101-151 in 1 BOX10/23/2019
    1NDC:73390-101-1415 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:73390-101-202 in 1 BOX12/09/2019
    2NDC:73390-101-1415 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34410/23/2019
    Labeler - Tilco Trading Pte. Ltd. (659506330)
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