Label: TOPCARE SORE THROAT HONEY LEMON FLAVOR- benzocaine, menthol lozenge

  • 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 February 25, 2014

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  • TopCare Sore Throat Honey Lemon Flavor

  • ACTIVE INGREDIENT

    Active ingredients (in each lozenge)Purpose
    Benzocaine 15 mgOral anesthetic
    Menthol 2.6 mgOral anesthetic
  • Uses

    temporarily relieves these symptoms:

    • occasional minor irritation, pain, sore mouth and sore throat
    • pain associated with canker sores
  • Warnings

    Allergy Alert: Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or any other "caine" anesthetics.

    Sore throat warning:

    Severe or persistent sore throat or sore throat accompanied by high fever, headache, rash, nausea, and vomiting may be serious. Consult a dentist or doctor right away. Do not use more than 2 days or administer to children under 5 years of age unless directed by a doctor.

    Stop Use and ask a doctor if

    • sore throat is severe or irritation, pain or redness persists or worsens
    • sore mouth symptom do not improve in 7 days

    If pregnant or breast-feeding, ask a health professional before use.

    Keep this and all drugs out of the reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    • adults and children 5 years of age and older: allow 1 lozenge to dissolve slowly in the mouth. May be repeated every 2 hours as needed or as directed by a doctor or dentist.

    • children under 5 years: ask a doctor

  • Other information

    • store at room temperature
    • protect from moisture
  • Inactive ingredients

    glucose syrup, honey, N A Flavoring, propylene glycol, sucrose, water, and  FD C yellow 5 (tartrazine), Soybean oil and corn starch used as processing aids.

  • Questions or comments?

    1-888-423-0139

  •  TopCare Sore Throat Lozenges Honey Lemon Flavor 18 Count (36800-812-18)

    TopCare

    FAST-ACTING RELIEF

    Sore Throat

    Lozenges

    MENTHOL • BENZOCAINE

    ORAL ANESTHETIC

    • Fast, soothing, temporary

    relief of minor sore throat

    pain and Irritation

    Honey Lemon Flavor

    COMPARE TO CEPACOL

    active ingredients

    18 LOZENGES

    DISTRIBUTED BY

    TOPCO ASSOCIATES LLC

    ELK GROVE VILLAGE, IL 60007

    1-888-423-0139 ©TOPCO BSS3114

    topcare@topco.com

    This product is not manufactured or distributed

    by Reckftt Bencldser owner af the registered

    trademark Cepacol.

    TOPCAREHoneyLemonFlavor

  • INGREDIENTS AND APPEARANCE
    TOPCARE SORE THROAT HONEY LEMON FLAVOR 
    benzocaine, menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-812
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE15 mg
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.6 mg
    Inactive Ingredients
    Ingredient NameStrength
    CORN SYRUP (UNII: 9G5L16BK6N)  
    HONEY (UNII: Y9H1V576FH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SUCROSE (UNII: C151H8M554)  
    WATER (UNII: 059QF0KO0R)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeROUNDSize23mm
    FlavorHONEY, LEMONImprint Code B
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-812-1818 in 1 CARTON
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35602/25/2014
    Labeler - Topco Associates LLC (006935977)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bestco, Inc.002149136manufacture(36800-812)
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