The following Structured Product Label (SPL) was submitted to the FDA by Spectra Medical Devices, Llc for the product Numstat Antiseptic And Pain Relieving Prep Pad (NDC 65282-1815). 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, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active Ingredients (per application in each pad)
Percent Purpose
Isopropyl Alcohol................................. 71% Antiseptic
Benzocaine......................................... 15% Topical Analgesic
Menthol.............................................. 1% Topical Analgesic
Antiseptic & Pain Relieving
Uses
• For the temporary relief of pain associated with needle sticks, minor
burns, sunburn, minor cuts, scrapes, minor skin irritations, and insect
bites • Reduces the risk of infection • Kills germs
Warnings
Flammable. Keep away from heat or open flame.
When using this product • Use glove with application hand or always wash application hand immediately after application
For external use only
Do not use • Avoid contact with eyes, mouth, or mucous membranes.
In case of contact with eyes, mouth, or mucous membranes, flush
with water, call a doctor.
Discontinue use if irritation occurs. 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.
Keep out of reach of children. If swallowed, call a doctor or poison control center.
Directions for Use
Adults and children 2 years of age and older.
• Apply to affected area. Do not apply more than 4 times daily.
• Apply pad solution to the skin and gently rub in and let dry.
• Test for effect by touching area before performing procedure
May need to reapply on certain skin types.
For children under 2 years of age, consult a doctor.
Other Information
• Protect from excessive heat.
Inactive Ingredients
Neopentyl Glycol Diheptanoate
Neopentyl Glycol Diheptanoate Isododecane
Purified Water
Questions or Comments?
Call (978) 657-0889 or visit num-stat.com
Antiseptic & Pain Relieving Prep Pad
NUMSTAT
Fast Needle Pain Relief
• Quickly Relieve Minor Topical Pain with 15% Benzocaine and 1% Menthol
• Easily Clean and Kill Germs with 71% Isopropyl Alcohol
Afraid of Needle Pain?
To Relieve Minor
Topical Pain Fast,
Gently Rub In and Let Dry!
Manufactured for:
Spectra Medical Devices, LLC
299 Ballardvale Street, Suite 1, Wilmington, MA 01887
NUMSTAT (TM) and © Copyright 2023
Spectra Medical Devices LLC, All Rights Reserved.
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