Label: ALCOHOL PREP PAD- isopropyl alcohol swab

  • NDC Code(s): 69139-001-01, 69139-001-02
  • Packager: YIWU HAODING MEDICAL CO.,LTD
  • 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 March 3, 2023

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  • Active Ingredient

    Isopropyl Alcohol 70%

  • Purpose

    Antiseptic

  • Use

    For preparation of skin prior to an injection 

  • Warnning

    For External use only.

    Flammabel,keep away from fire or flame

    Do not use

    • with electrocautery procedures or  in the eyes,

    stop use if irritation and redness develop.  if condition persists for more than 72 hours consult a physician.

    Keep out of reach of children

    if ingested,do not induce vomiting,get medical help or contact a poison  Control Center right immediately.

  • Directions

    Apply alcohol as needed to clean intended area ,discard after single use.

  • Inactive Ingredients

    purified water

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    ALCOHOL PREP PAD 
    isopropyl alcohol swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69139-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 30 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69139-001-011 in 1 BAG03/04/2023
    10.21 mL in 1 POUCH; Type 0: Not a Combination Product
    2NDC:69139-001-022 in 1 BAG03/04/2023
    20.21 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/04/2023
    Labeler - YIWU HAODING MEDICAL CO.,LTD (421362384)
    Establishment
    NameAddressID/FEIBusiness Operations
    YIWU HAODING MEDICAL CO.,LTD421362384manufacture(69139-001)
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