FDA Label for Benzocaine

View Indications, Usage & Precautions

Benzocaine Product Label

The following document was submitted to the FDA by the labeler of this product Dynarex Corporation. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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


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