NUMSTAT ANTISEPTIC AND PAIN RELIEVING PREP PAD- alcohol, menthol, and benzocaine prep pad swab

NUMSTAT Antiseptic and Pain Relieving Prep Pad by

Drug Labeling and Warnings

NUMSTAT Antiseptic and Pain Relieving Prep Pad by is a Otc medication manufactured, distributed, or labeled by Spectra Medical Devices, LLC, Safetec Of America Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Active Ingredients (per application in each pad)

Percent Purpose

Isopropyl Alcohol................................. 71% Antiseptic

Benzocaine......................................... 15% Topical Analgesic

Menthol.............................................. 1% Topical Analgesic

Purpose

Antiseptic & Pain Relieving

Uses

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

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

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.

Stop use

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

Keep out of reach of children. If swallowed, call a doctor or poison control center.

Directions

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

Other Information

Protect from excessive heat.

Inactive Ingredients

Inactive Ingredients

Neopentyl Glycol Diheptanoate

Neopentyl Glycol Diheptanoate Isododecane

Purified Water

Questions or Comments?

Questions or Comments?

Call (978) 657-0889 or visit num-stat.com

Carton Information

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.

Package Label Principal Display Panel

NUMSTAT Carton

INGREDIENTS AND APPEARANCE

NUMSTAT ANTISEPTIC AND PAIN RELIEVING PREP PAD 
alcohol, menthol, and benzocaine prep pad swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65282-1815
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	15 g  in 100 g
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	71 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65282-1815-1	30 in 1 CARTON	01/01/2023
1		1 g in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 65282-1815-2	100 in 1 CARTON	01/01/2023
2		1 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M003	01/01/2023

Labeler - Spectra Medical Devices, LLC (118301171)

Registrant - Spectra Medical Devices, LLC (118301171)

Establishment
Name	Address	ID/FEI	Business Operations
Safetec Of America Inc.		874965262	manufacture(65282-1815)