EAR WAX REMOVAL DROPS (CARBAMIDE PEROXIDE - 6.5%) SOLUTION/ DROPS [NUCARE PHARMACEUTICALS,INC.]

EAR WAX REMOVAL DROPS (CARBAMIDE PEROXIDE - 6.5%) SOLUTION/ DROPS [NUCARE PHARMACEUTICALS,INC.]
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NDC 66267-976-15
Set ID 88403f3a-4de0-082c-e053-2a95a90a7cba
Category HUMAN OTC DRUG LABEL
Packager NuCare Pharmaceuticals,Inc.
Generic Name
Product Class
Product Number
Application Number PART344
  • 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.
  • Inactive ingredients

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

  • Principal Display Panel - Carton label 0.5 FL OZ

    pdp

  • INGREDIENTS AND APPEARANCE
    EAR WAX REMOVAL DROPS 
    carbamide peroxide - 6.5% solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66267-976(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 (UNII: 1Q73Q2JULR)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TARTARIC ACID (UNII: W4888I119H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66267-976-1515 mL in 1 BOX; Type 0: Not a Combination Product05/06/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34405/27/2014
    Labeler - NuCare Pharmaceuticals,Inc. (010632300)
    Establishment
    NameAddressID/FEIBusiness Operations
    NuCare Pharmaceuticals,Inc.010632300relabel(66267-976)