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

  • 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 February 17, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients

    Isopropyl Alcohol 70%

  • PURPOSE

    Purpose

    Antiseptic Cleanser

  • INDICATIONS & USAGE

    Use For preparation of the skin prior to an injection

  • WARNINGS

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

  • 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  Store at room temperature 15ο​​ - 30ο C (59ο - 86ο F)

  • INACTIVE INGREDIENT

    Inactive Ingredient  purified water

  • Product Label

    MED NAP 

    NDC# 59647-500-01

    STERILE ALCOHOL
    PREP PAD

    Reorder No. 3113

    LATEX FREE

    1 PAD

    MEDIUM

    SATURATED WITH 70% ISOPROPYL ALCOHOL
    FOR EXTERNAL USE ONLY
    STERILE UNLESS POUCH IS OPENED OR DAMAGED

    MADE IN U.S.A.

    Made By:

    MED-NAP LLC

    Brooksville, FL 34601

    www.mednap.us

    MADE IN U.S.A.

    LOT:  XXXXXX         EXP: XX/XX                  1

    500-01 Pouch

    500-01 Box

    res

  • INGREDIENTS AND APPEARANCE
    MED-NAP STERILE ALCOHOL PREP PADS 
    isopropyl alcohol swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59647-500
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL0.70 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59647-500-01200 in 1 BOX02/14/2020
    11 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 finalpart333A02/14/2020
    Labeler - Med-Nap LLC (079086400)
    Registrant - Med-Nap LLC (079086400)
    Establishment
    NameAddressID/FEIBusiness Operations
    Med-Nap LLC079086400manufacture(59647-500)
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