Label: ALCOHOL PREP PAD- isopropyl alcohol swab

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 March 1, 2010

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  • PRINCIPAL DISPLAY PANEL

    Item# 83791-818-012      NDC# 42947-650-12      Qty. 1ea

    Alcohol Prep Pad

    Antiseptic * Medium, 1-ply * Saturated with 70% isopropyl alcohol

    Sterile if unopened, undamaged

    For External Use Only

    Manufactured by:

    Wuxi Medical Instrument Factory

    No.86 East Street, Zhangjing, Wuxi, Jiangsu 214194 China

    Made in China


  • ACTIVE INGREDIENT

    Active Ingredient

    Isopropyl Alcohol, 70% v/v

  • PURPOSE

    Purpose

    Antiseptic

  • WHEN USING

    Use

    For preparation of skin prior to 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

  • STOP USE

    Stop use

    if irritation or redness develop.

    if the condition persists for more than 71 hours, consult a doctor.


  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    If swallowed, get medical help or contact Poison Control Center right away.

  • INDICATIONS & USAGE

    Directions

    Wipe injection site vigorously and discard

  • INACTIVE INGREDIENT

    Inactive ingredient

    purified water

  • PRINCIPAL DISPLAY PANEL

    Image of Pouch Label

    Alcohol Prep Pad

  • INGREDIENTS AND APPEARANCE
    ALCOHOL PREP PAD 
    isopropyl alcohol swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42947-650
    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) 0.3 mL  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42947-650-120.4 mL in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33301/01/2009
    Labeler - Wuxi Medical Instrument Factory (421292863)
    Registrant - Wuxi Medical Instrument Factory (421292863)
    Establishment
    NameAddressID/FEIBusiness Operations
    Wuxi Medical Instrument Factory421292863manufacture
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