Antiseptic & Pain Relieving Prep Pad

Antiseptic & Pain Relieving Prep Pad
SPL v2
SPL
SPL Set ID 07d20040-9dd9-0aba-e063-6294a90ab7cf
Route
TOPICAL
Published
Effective Date 2023-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (15 g) Isopropyl Alcohol (71 g) Menthol (1 g)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-01-01

Description

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


Medication Information

Purpose

Antiseptic & Pain Relieving

Description

Active Ingredients (per application in each pad) Percent Purpose Isopropyl Alcohol................................. 71% Antiseptic Benzocaine......................................... 15% Topical Analgesic Menthol.............................................. 1% Topical Analgesic

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

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.

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

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.

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.

Other Information

Other Information

• Protect from excessive heat.

Active Ingredients

Active Ingredients (per application in each pad)

Percent Purpose

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

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

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

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.

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

Keep Out of Reach of Children

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

Package Label Principal Display Panel

NUMSTAT Carton


Structured Label Content

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

Purpose

Antiseptic & Pain Relieving

Stop Use (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.

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

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.

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.

Other Information

Other Information

• Protect from excessive heat.

Active Ingredients

Active Ingredients (per application in each pad)

Percent Purpose

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

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

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

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.

Inactive Ingredients

Inactive Ingredients

Neopentyl Glycol Diheptanoate

Neopentyl Glycol Diheptanoate Isododecane

Purified Water

Questions Or Comments? (Questions or Comments?)

Questions or Comments?

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

Keep Out of Reach of Children (Keep out of reach of children)

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

Package Label Principal Display Panel

NUMSTAT Carton


Advanced Ingredient Data


Raw Label Data

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