Active Ingredient
Active Ingredient Purpose
Benzocaine, 6% w/v Topical Analgesic
Isopropyl Alcohol, 70% w/v Antiseptic
Benzocaine
FDA Label NDC 67777-235
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 67777-235). 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, 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
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)
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