BACTIMICINA FOR SORE THROAT- benzocaine lozenge 
DLC Laboratories, Inc.

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.

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Bactimicina Lozenge

Drug Fact

Active Ingredient (in each lozenge)

Benzocaine 15 mg

Purpose

Oral anesthetic/Analgesic

Use

temporarily relieve:

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

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

Other information

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

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

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)

Revised: 12/2021
Document Id: d3abce13-cc88-e661-e053-2a95a90a1b7c
Set id: d3abce13-cc87-e661-e053-2a95a90a1b7c
Version: 1
Effective Time: 20211221
 
DLC Laboratories, Inc.