FDA.reportPublic FDA data

Bactimicina for Sore Throat

Manufacturer
DLC Laboratories, Inc.
Effective date
2020-12-10
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 23:02:32

Label at a glance#

ProductBactimicina for Sore Throat
Active ingredientbenzocaine
Label structure11 sections

Indications and uses

temporarily relieves: occasional minor irritation, pain, sore mouth and sore throat

Dosage and administration

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.

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each lozenge)

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 15 mg

Purpose

OTC - PURPOSE SECTION

Oral anesthetic/Analgesic

Uses

INDICATIONS & USAGE SECTION

temporarily relieves:

  • occasional minor irritation, pain, sore mouth and sore throat

Warnings

WARNINGS SECTION

Methemoglobinemia warning

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

OTC - DO NOT USE SECTION

  • for teething
  • in children under 5 years of age

When using this product

OTC - WHEN USING SECTION

  • do not exceed recommended dosage

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn syrup, flavor, sucrose, yellow #6

Questions

OTC - QUESTIONS SECTION

1-800-858-3889

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 18 Lozenge Blister Pack Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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
PRINCIPAL DISPLAY PANEL - 18 Lozenge Blister Pack Box

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
24286-157224286-1572-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
benzocaineU3RSY48JW5ACTIB
Corn Syrup9G5L16BK6NIACT
FD&C Yellow No. 6H77VEI93A8IACT
GlycerinPDC6A3C0OXIACT
SucroseC151H8M554IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d24204d1-8500-0e67-e053-2a95a90a35a3b269c01a-36d6-403b-aa45-29b3243e40122021-12-03WarningsExact identifier
spl set id: b269c01a-36d6-403b-aa45-29b3243e4012

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.