BACTIMICINA FOR SORE THROAT (BENZOCAINE) LOZENGE [DLC LABORATORIES, INC.]

BACTIMICINA FOR SORE THROAT (BENZOCAINE) LOZENGE [DLC LABORATORIES, INC.]
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NDC 24286-1572-1
Set ID b269c01a-36d6-403b-aa45-29b3243e4012
Category HUMAN OTC DRUG LABEL
Packager DLC Laboratories, Inc.
Generic Name
Product Class
Product Number
Application Number PART356
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each lozenge)

    Benzocaine 15 mg

  • Purpose

    Oral anesthetic/Analgesic

  • Uses

    temporarily relieves:

    • occasional 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 develops:

    • 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 reaction 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

    corn syrup, flavor, sucrose, yellow #6

  • Questions

    1-800-858-3889

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    DLC Laboratories, Inc.
    Paramount, CA 90723 USA

  • PRINCIPAL DISPLAY PANEL - 18 Lozenge Blister Pack Box

    Fast Acting

    TRUSTED SINCE 1978

    New
    Look

    Maximum Strength

    Bactimicina®

    Sore Throat Pain Relief

    Benzocaine Oral Anesthetic

    Orange Flavor

    18 Lozenges

    PRINCIPAL DISPLAY PANEL - 18 Lozenge Blister Pack Box
  • INGREDIENTS AND APPEARANCE
    BACTIMICINA FOR SORE THROAT 
    benzocaine lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24286-1572
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    benzocaine (UNII: U3RSY48JW5) (benzocaine - UNII:U3RSY48JW5) benzocaine15 mg
    Inactive Ingredients
    Ingredient NameStrength
    Corn Syrup (UNII: 9G5L16BK6N)  
    FD&C Yellow No. 6 (UNII: H77VEI93A8)  
    Glycerin (UNII: PDC6A3C0OX)  
    Sucrose (UNII: C151H8M554)  
    Product Characteristics
    ColorORANGEScoreno score
    ShapeOVALSize20mm
    FlavorORANGEImprint Code P
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24286-1572-13 in 1 BOX01/30/2013
    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 finalpart35601/30/2013
    Labeler - DLC Laboratories, Inc. (093351930)

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