Label: MED-NAP STERILE ALCOHOL PREP PADS- isopropyl alcohol swab

  • NDC Code(s): 0924-0500-00, 0924-0500-01, 0924-0500-02, 0924-0500-04
  • Packager: Acme United Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated July 12, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Isopropyl Alcohol 70% v/v

  • PURPOSE

    Purpose

    Antiseptic Cleanser

  • INDICATIONS & USAGE

    Use For preparation of the skin prior to an injection

  • DO NOT USE

    Do Not Use ● with electrocautery procedures ● In the eyes. If contact occurs, flush

    eyes with water

  • STOP USE

    Slop Use If irritation or redness develop. If condition persists consult your health care practitioner.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed get medical help or consult a Poison

    Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions ● Wipe injection site vigorously and discard.

  • OTHER SAFETY INFORMATION

    Other Information Sterile unless pouch is opened or damaged. Store at room temperature 15 ο​​ - 30 ο C (59 ο - 86 ο F)

  • INACTIVE INGREDIENT

    Inactive Ingredient purified water

    Warnings● For external use only ● Flammable, keep away from fire or flame

  • QUESTIONS

    Questions 800-835-2263

  • PRINCIPAL DISPLAY PANEL

    Prep Pad BoxPrep Pad Box

  • INGREDIENTS AND APPEARANCE
    MED-NAP STERILE ALCOHOL PREP PADS 
    isopropyl alcohol swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0924-0500
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL0.7 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0924-0500-01200 in 1 BOX07/12/2021
    11 mL in 1 POUCH; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug
    2NDC:0924-0500-001 mL in 1 POUCH; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug07/12/2021
    3NDC:0924-0500-0250 in 1 BOX07/12/2022
    31 mL in 1 POUCH; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug
    4NDC:0924-0500-04100 in 1 BOX07/12/2022
    41 mL in 1 POUCH; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/12/2021
    Labeler - Acme United Corporation (001180207)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acme United Corporation045924339label(0924-0500) , pack(0924-0500)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acme United Corporation080119599label(0924-0500) , pack(0924-0500)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acme United Corporation117825595manufacture(0924-0500)
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