Benzocaine Swab
FDA Label NDC 67777-246

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dynarex Corporation for the product Benzocaine (NDC 67777-246). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose for benzocaine, keep out of reach of children, indications and usage, warnings, dosage, inactive ingredients, do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

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