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Benzocaine by Dynarex Corporation

Medically reviewed on June 15, 2018

Dosage form: swab
Ingredients: BENZOCAINE 60mg in 1mL
Labeler: Dynarex Corporation
NDC Code: 67777-246

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.

1408

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

Dynarex Sting and Bite

Benzocaine.jpg

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) BENZOCAINE60 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ISOPROPYL ALCOHOL 
WATER 
Packaging
#Item CodePackage Description
1NDC:67777-246-012 mL 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)

 
Dynarex Corporation

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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