Label: BACTIMICINA FOR SORE THROAT- benzocaine lozenge

  • NDC Code(s): 24286-1577-1
  • Packager: DLC Laboratories, Inc.
  • 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 December 21, 2021

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  • Drug Fact

  • Active Ingredient (in each lozenge)

    Benzocaine 15 mg

  • Purpose

    Oral anesthetic/Analgesic

  • Use

    temporarily relieve:

    • occational minor irritation, pain, sore mouth and sore throat
  • Warnings

    Methemoglobinemia warning:

    Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care developes:

    • pale, gray, or blue colored skin (cyanosis)
    • shortness of breath
    • headache
    • dizziness or lightheadedness
    • rapid heart rate
    • fatigue or lack of energy

    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. If skin reation occurs, stop use and seek medical help right away.

    Sore throat warning:

    If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly.

    Do not use

    • for teething
    • in children under 5 years of age

    When using this product

    • do not exceed recommended dosage

    Stop use and ask a doctor if

    • sore mouth symptoms do not improve in 7 days
    • irritation, pain or redness persists or worsens
    • swelling, rash or fever develops

    If pregnant or breast-feeding

    ask a health professional before use

    Keep out of reach of children

    In case of overdose, or if more than used for pain relief is accidentally swallowed, get medical help or contact a Poison COntrol Center immediately

  • Directions

    • adults and children 5 years of age and older:

    Dissolve 1 lozenge slowly in the mouth. May be repeated every 2 hours as needed or as directed by a doctor or dentist.

    • children under 5 years of age: do not use.
  • Other information

    • protect from moisture
    • store at room temperature
    • check expiration date before using
  • Inactive Ingredients

    dextrose, FD&C yellow #6, FD&C red #40, corn syrup, hydrogenated cottonseed oil, natural and artificial flavor, propylene glycol, sucrose

  • Question

    1-800-858-3889

  • SPL UNCLASSIFIED SECTION

    Distributed by

    De La Cruz Products

    A Division of DLC Laboratories, Inc.

    Paramount, CA 90723 USA

  • Principle Display

    Fast Acting

    Trusted since 1978

    New Look

    Maximum Strength

    Bactimicina ®

    Sore Throat Pain Relief

    Benzocain Oral Anesthetic

    Orange Flavor

    18 Lozenges

    Bactimicina Lozenges

  • INGREDIENTS AND APPEARANCE
    BACTIMICINA FOR SORE THROAT 
    benzocaine lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24286-1577
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE15 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SUCROSE (UNII: C151H8M554)  
    HYDROGENATED COTTONSEED OIL (UNII: Z82Y2C65EA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    CORN SYRUP (UNII: 9G5L16BK6N)  
    Product Characteristics
    ColororangeScoreno score
    ShapeOVALSize20mm
    FlavorORANGEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24286-1577-13 in 1 BOX12/21/2021
    16 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35612/21/2021
    Labeler - DLC Laboratories, Inc. (093351930)
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