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Name:Benzocaine
Manufacturer:Dynarex Corporation
Category:Over-the-counter (OTC) Marketed Drugs


Benzocaine Sting & Bite Pad

BENZOCAINE  - benzocaine swab 
Dynarex Corporation

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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Benzocaine Sting & Bite Pad

Active Ingredient

Active Ingredient                             Purpose                  

Benzocaine, 6% w/v                       Topical Analgesic

Isopropyl Alcohol, 70% w/v              Antiseptic

Purpose

  • For temporary relief of pain and itching associated with minor burns, scrapes and insect bites.

Keep Out of Reach of Children

  • Keep out of reach of children.
  • If swallowed, get medical help or contact a Poison Control Center.

Indications and Usage

  • For temporary relief of pain and itching associated with minor burns, scrapes and insect bites.

Warnings

Warnings:

  • For external use only.
  • Flammable, keep away from fire or flame.

Dosage

Directions:

  • Adults and children 2 years of age and older, apply to affected area 3-4 times daily.
  • Children under 2 years; consult a physician.






Inactive Ingredients

  • Inactive Ingredient: Water.

Do Not Use

Do not use: 

  • With electrocautery procedures.
  • In the eyes.

Stop Use

Stop use:

  • If irritation and redness develop.
  • If condition persists for more than 72 hours, consult a physician.

Storage and Handling

  • Avoid excessive heat.
  • Store at room temperature: 15 - 30 degrees C (59 - 86 degrees F)

Principal Display

Sting and Bite Pad

Benzocaine





BENZOCAINE 
benzocaine swab
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:67777-235
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOCAINE (BENZOCAINE) BENZOCAINE 0.12 mL
Inactive Ingredients
Ingredient Name Strength
ISOPROPYL ALCOHOL  
WATER  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67777-235-01 3000 PACKET ( SWAB) in 1 CASE contains a PACKET
1 1 SWAB ( SWAB) in 1 PACKET This package is contained within the CASE (67777-235-01)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part348 01/24/2011

Labeler - Dynarex Corporation (008124539)
Registrant - Dynarex Corporation (008124539)
Establishment
Name Address ID/FEI Operations
Taizhou Kanglin Health Protection Products Co Ltd 530576131 manufacture

Revised: 03/2011 Dynarex Corporation



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


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