NUMSTAT Antiseptic and Pain Relieving Prep Pad

Manufacturer
Spectra Medical Devices, LLC | Safetec Of America Inc.
Effective date
2023-12-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:05:03

Label at a glance#

ProductNUMSTAT Antiseptic and Pain Relieving Prep Pad
Active ingredientBENZOCAINE, ISOPROPYL ALCOHOL, MENTHOL
Label structure13 sections

Indications and 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

Dosage and administration

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.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients (per application in each pad)

Percent Purpose

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

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

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

Purpose

OTC - PURPOSE SECTION

Antiseptic & Pain Relieving

Uses

INDICATIONS & USAGE SECTION

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 SECTION

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

OTC - DO NOT USE SECTION

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

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

SPL UNCLASSIFIED SECTION

Other Information

• Protect from excessive heat.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive Ingredients

Neopentyl Glycol Diheptanoate

Neopentyl Glycol Diheptanoate Isododecane

Purified Water

Questions or Comments?

OTC - QUESTIONS SECTION

Questions or Comments?

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

Carton Information

SPL UNCLASSIFIED SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NUMSTAT CartonNUMSTAT Carton

NUMSTAT Carton

Numstat Packet FrontNumstat Packet Front

Numstat Packet BackNumstat Packet Back

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2667820benzocaine 15 % / isopropyl alcohol 71 % / menthol 1 % Medicated PadPSN2
2667826NUMSTAT 71 % / 15 % / 1 % Medicated PadPSN2
2667826benzocaine 150 MG/ML / isopropyl alcohol 0.71 ML/ML / menthol 10 MG/ML Medicated Pad [Numstat]SBD2
2667820benzocaine 150 MG/ML / isopropyl alcohol 0.71 ML/ML / menthol 10 MG/ML Medicated PadSCD2
2667820benzocaine 15 % / isopropyl alcohol 71 % / menthol 1 % Medicated PadSY2
2667826Numstat (benzocaine 15 % / isopropyl alcohol 71 % / menthol 1 % ) Medicated PadSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BENZOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65282-1815-1NUMSTAT Antiseptic and Pain Relieving Prep Pad30 in 1 CARTONSWAB302
65282-1815-1NUMSTAT Antiseptic and Pain Relieving Prep Pad1 g in 1 PACKETSWAB12
65282-1815-2NUMSTAT Antiseptic and Pain Relieving Prep Pad100 in 1 CARTONSWAB1002
65282-1815-2NUMSTAT Antiseptic and Pain Relieving Prep Pad1 g in 1 PACKETSWAB12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65282-1815NUMSTAT ANTISEPTIC AND PAIN RELIEVING PREP PAD (ALCOHOL, MENTHOL, AND BENZOCAINE PREP PAD) SWAB [SPECTRA MEDICAL DEVICES, LLC]2Current NDC, 4 package rows20231221_07d20040-9dd9-0aba-e063-6294a90ab7cf.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65282-181565282-1815-1, 65282-1815-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
BENZOCAINEU3RSY48JW5ACTIB
ISOPROPYL ALCOHOLND2M416302ACTIB
MENTHOLL7T10EIP3AACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NUMSTAT Antiseptic and Pain Relieving Prep PadALCOHOL, MENTHOL, AND BENZOCAINE PREP PADSpectra Medical Devices, LLC07d20040-9dd9-0aba-e063-6294a90ab7cf2023-12-20WarningsExact identifier
ndc (package): 65282-1815-2
ndc (package): 65282-1815-1
ndc (product): 65282-1815
ndc11 (package): 65282181501
ndc11 (package): 65282181502
spl id: 0ceeef4e-90fe-d542-e063-6394a90abc8d
spl set id: 07d20040-9dd9-0aba-e063-6294a90ab7cf

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.