Active Ingredients
Benzocaine 10% w/w
Benzethonium Chloride .2% w/w
Menthol .33% w/w
Prostat Burn First Aid
FDA Label NDC 58228-0105
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Prostat First Aid for the product Prostat Burn First Aid (NDC 58228-0105). 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 ingredients, purpose, uses, warnings, do not use, stop use and ask a doctor if, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical Anesthetic
Topical Antiseptic
Topical Anesthetic
Uses
For temporary relief of pain, itching and to help protect against infection in
minor cuts and scrapes
burns
sunburns
insect bites
minor skin irritations
Warnings
For external use only
Flammable
keep away from fire or flame
contents under pressure
do not puncture or incinerate container
do not expose to temperatures above 120° F
Do Not Use
in or near eyes or other mucous membranes
in case of serious burns
in deep puncture wounds
for prolonged period of time
on large portions of the body
Stop Use And Ask A Doctor If
redness, swelling, or irritation occurs
infection occurs
conditions worsen or symptoms persist for more than 7 days
Directions
clean the affected area
shake can well before using
hold 4-6 inches from surface and spray area until wet
for adult institutional use only
not intended for use on children
Other Information
avoid spraying in eyes
use only as directed
intentional misuse by deliberately concentrating and inhaling the contents may be harmful or fatal
Inactive Ingredients
dipropylene glycol, isobutane, n-butane, propane
Principal Display
Image Description (Ps Burn)
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