Bactimicina Lozenge

Bactimicina Lozenge
SPL v2
SPL
SPL Set ID d3abce13-cc87-e661-e053-2a95a90a1b7c
Route
ORAL
Published
Effective Date 2021-12-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (15 mg)
Inactive Ingredients
Fd&c Red No. 40 Propylene Glycol Sucrose Hydrogenated Cottonseed Oil Fd&c Yellow No. 6 Dextrose Corn Syrup

Identifiers & Packaging

Pill Appearance
Shape: oval Color: orange Size: 20 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-12-21 Until 2026-10-31

Description

Benzocaine 15 mg

Purpose

Oral anesthetic/Analgesic


Medication Information

Purpose

Oral anesthetic/Analgesic

Description

Benzocaine 15 mg

Use

temporarily relieve:

  • occational minor irritation, pain, sore mouth and sore throat
Section 42229-5

Distributed by

De La Cruz Products

A Division of DLC Laboratories, Inc.

Paramount, CA 90723 USA

Question

1-800-858-3889

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.
Do Not Use
  • for teething
  • in children under 5 years of age
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.

Other Information
  • protect from moisture
  • store at room temperature
  • check expiration date before using
Principle Display

Fast Acting

Trusted since 1978

New Look

Maximum Strength

Bactimicina ®

Sore Throat Pain Relief

Benzocain Oral Anesthetic

Orange Flavor

18 Lozenges

Inactive Ingredients

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

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.

When Using This Product
  • do not exceed recommended dosage
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
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

Active Ingredient (in Each Lozenge)

Benzocaine 15 mg


Structured Label Content

Use

temporarily relieve:

  • occational minor irritation, pain, sore mouth and sore throat
Section 42229-5 (42229-5)

Distributed by

De La Cruz Products

A Division of DLC Laboratories, Inc.

Paramount, CA 90723 USA

Purpose

Oral anesthetic/Analgesic

Question

1-800-858-3889

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.
Do Not Use (Do not use)
  • for teething
  • in children under 5 years of age
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.

Other Information (Other information)
  • protect from moisture
  • store at room temperature
  • check expiration date before using
Principle Display

Fast Acting

Trusted since 1978

New Look

Maximum Strength

Bactimicina ®

Sore Throat Pain Relief

Benzocain Oral Anesthetic

Orange Flavor

18 Lozenges

Inactive Ingredients

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

Sore Throat Warning: (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.

When Using This Product (When using this product)
  • do not exceed recommended dosage
Methemoglobinemia Warning: (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
Stop Use and Ask A Doctor If (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 (If pregnant or breast-feeding)

ask a health professional before use

Keep Out of Reach of Children (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

Active Ingredient (in Each Lozenge) (Active Ingredient (in each lozenge))

Benzocaine 15 mg


Advanced Ingredient Data


Raw Label Data

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