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Name:Bactimicina For Sore Throat
Manufacturer:Dlc Laboratories, Inc.
Category:Over-the-counter (OTC) Marketed Drugs


Bactimicina For Sore Throat

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 For Sore Throat

Active ingredient (in each lozenge)

Benzocaine 15mg

Purpose

Oral anesthetic/Analgesic

Uses

temporarily relieves

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

Warnings

Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache nausea, and vomiting may be serious. Consult a doctor promptly. Do not use more than 2 days or administer to children under 5 years of age unless directed by a doctor.

Do not use

  • if you have a history of allergy to any local anesthetics such as procaine, butacaine, benzocaine, or any other "caine" anesthetics.

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

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 of worsens
  • swelling, rash or fever develops
  • difficulty in breathing occurs

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 right away.


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: consult a doctor or dentist

Other information

  • protect from moisture
  • store at room temperature
  • check box for expiration date before using
  • do not use if blister units are torn, broken or show any signs of tampering

Inactive Ingredients

dextrose, FDandC Red #40, FDandC Yellow 6, flavor, glucose, glycerin, sucrose

Questions:

1-800-858-3889
www.dlclabs.com

Distributed by:

DE LA CRUZ PRODUCTS
A Division of DLC Laboratories, Inc.
Paramount, CA 90723 USA

Questions: 1-800-858-3889
www.dlclabs.com

Do not use if blister units are torn, broken or show any signs of tampering.

Bactimicina for SoreThroat
Benzocaine Oral Anesthetic

Instant Relief!
Fruit Flavor
18 Lozenges MAXIMUM STRENGTH

Bactimicina Lozenge

Bactimicina Lozenge


BACTIMICINA FOR SORE THROAT 
benzocaine lozenge
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:24286-1520
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOCAINE (BENZOCAINE) BENZOCAINE 15 mg
Inactive Ingredients
Ingredient Name Strength
DEXTROSE  
FD&C RED NO. 40  
FD&C YELLOW NO. 6  
DEXTROSE  
GLYCERIN  
SUCROSE  
Product Characteristics
Color orange (Orange) Score no score
Shape SQUARE (Square) Size 20mm
Flavor Imprint Code H15
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:24286-1520-1 3 BLISTER PACK ( BLISTER PACK) in 1 BOX contains a BLISTER PACK
1 6 LOZENGE ( LOZENGE) in 1 BLISTER PACK This package is contained within the BOX (24286-1520-1)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part356 05/24/2011

Labeler - DLC Laboratories, Inc. (093351930)

Revised: 05/2011 DLC Laboratories, Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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