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

  • NDC Code(s): 65282-1815-1, 65282-1815-2
  • Packager: Spectra Medical Devices, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 20, 2023

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  • 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

    NUMSTAT Carton

    Numstat Packet Front

    Numstat Packet Back

  • INGREDIENTS AND APPEARANCE
    NUMSTAT ANTISEPTIC AND PAIN RELIEVING PREP PAD 
    alcohol, menthol, and benzocaine prep pad swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65282-1815
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE15 g  in 100 g
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL71 g  in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65282-1815-130 in 1 CARTON01/01/2023
    11 g in 1 PACKET; Type 0: Not a Combination Product
    2NDC:65282-1815-2100 in 1 CARTON01/01/2023
    21 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00301/01/2023
    Labeler - Spectra Medical Devices, LLC (118301171)
    Registrant - Spectra Medical Devices, LLC (118301171)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec Of America Inc.874965262manufacture(65282-1815)
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