NUMSTAT ANTISEPTIC AND PAIN-RELIEVING PREP PAD- antiseptic and pain-relieving prep pad swab

Drug Labeling and Warnings

Drug Details [pdf]

Active Ingredients

Active Ingredients( per application in each pad)

Percent and Purpose

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

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

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

Warnings

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

Directions for Use.

Adults and children 2 years of age and older.

• Apply to the affected area.Do not appy more than 4 times daily.
• Apply pad to the skin, thoroughly rub in for 60 seconds and let dry.
• Test for effect by touching the area beform performing procedure. May need to reapply on certain skin types.
• For children under 2 years of age, consult a doctor.

Inactive Ingredients

Inactive Ingredients

Neopentyl Glycol Diheptanoate

Neopentyl Glycol Diheptanoate Isododecane

Purified Water

Other Information

Protect from Excessive Heat.

Uses

For the temporary relief of pain associated with needle sticks, minor burns, sunburn, minor cuts, scrapes, skin irritation and insect bites.

• Reduces risk of infection.
• Kills germs.

Purpose:

Antiseptic and Pain Relieving Prep Pad

Keep Out of the Reach of Children.

Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Carton -50ct

Carton Information

Antiseptic and Pain Relieving Prep Pad

NumStat , Fast Needle Pain Relief. Tired of Needle Pain?

• Quickly Relieve Minor Topical Pain with 15% Benzocaine and 1% Menthol
• Easily Clean and Kill Germs with71% Isopropyl Alcohol
• To Relieve Pain Rub in for 60 seconds and Let Dry!

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

INGREDIENTS AND APPEARANCE

NUMSTAT ANTISEPTIC AND PAIN-RELIEVING PREP PAD 
antiseptic and pain-relieving prep pad swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61010-8203
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)	2 g  in 100 g
NEOPENTYL GLYCOL (UNII: QI80HXD6S5)	1 g  in 100 g
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61010-8203-2	50 in 1 CARTON	04/15/2026
1	NDC: 61010-8203-1	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	04/15/2026

Labeler - Safetec of America Inc. (874965262)

Registrant - Safetec of America Inc. (874965262)

Establishment
Name	Address	ID/FEI	Business Operations
Safetec of America Inc.		874965262	manufacture(61010-8203)