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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Active Ingredient

Active Ingredient                             Purpose                  

Benzocaine, 6% w/v                       Topical Analgesic


Purpose for Benzocaine

  • For temporary relief of pain and itching associated with minor burns, sunburn, scrapes and insect bites or minor skin irritations

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, sunburn, scrapes and insect bites or minor skin irritations.

Warnings

Warnings: Benzocaine

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

Dosage

Directions:

  • For adults and children 2 years of age and older, apply to affected area not more than 3-4 times daily.
  • Children under 2 years; consult a physician.






Inactive Ingredients

  • Inactive Ingredients: Isopropyl Alcohol, Water.

Do Not Use

Do not use: 

  • With electrocautery procedures.

Stop Use

Stop use:

  • If irritation and redness develop.
  • If condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use and consult a doctor.

Storage and Handling

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

Principal Display Panel

Benzocaine

Benzocaine











BENZOCAINE 
benzocaine swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-246
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE) BENZOCAINE0.12 mL
Inactive Ingredients
Ingredient NameStrength
ISOPROPYL ALCOHOL 
WATER 
Packaging
#Item CodePackage Description
1NDC:67777-246-013000 in 1 CASE
11 in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34807/20/2011
Labeler - Dynarex Corporation (008124539)
Registrant - Dynarex Corporation (008124539)

Revised: 08/2011
 
Dynarex Corporation