The following Structured Product Label (SPL) was submitted to the FDA by Safetec Of America Inc. for the product Numstat Antiseptic And Pain-relieving Prep Pad (NDC 61010-8203). 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, warnings, directions for use, inactive ingredients, other information, uses, purpose:, keep out of the reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active Ingredients( per application in each pad)
Percent and Purpose
Isopropyl Alcohol.......................................71% Antiseptic
Benzocaine................................................15% Topical Analgesic
Menthol......................................................1% Topical Analgesic
For External Use Only.
Flammable. Keep away from heat or open flame
Do not use - in eyes, mouth or mucous membranes. In caseof contact with eyes, mouth or mucous membranes, flush with water, calla doctor.
Directions for Use.
Adults and children 2 years of age and older.
Inactive Ingredients
Neopentyl Glycol Diheptanoate
Neopentyl Glycol Diheptanoate Isododecane
Purified Water
Protect from Excessive Heat.
For the temporary relief of pain associated with needle sticks, minor burns, sunburn, minor cuts, scrapes, skin irritation and insect bites.
Antiseptic and Pain Relieving Prep Pad
Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.
Carton Information
Antiseptic and Pain Relieving Prep Pad
NumStat , Fast Needle Pain Relief. Tired of Needle Pain?
NumStat is a Trademark of Spectra Medical Devices, LLC.©2023. Spectra Medical Devices,LLC. All Rights Reserved.
Distributed by SAFETEC OF AMERICA INC.
Buffalo,NY 14215
800-456-7077
www.safetec.com
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