Label: ALCOHOL PREP PAD- isopropyl alcohol swab

  • NDC Code(s): 42339-001-01, 42339-001-02, 42339-001-03, 42339-001-04, view more
    42339-001-05, 42339-001-06, 42339-001-07, 42339-001-08, 42339-001-09, 42339-001-10, 42339-001-11, 42339-001-12, 42339-001-13, 42339-001-14, 42339-001-15, 42339-001-16, 42339-001-17, 42339-001-18, 42339-001-19, 42339-001-20, 42339-001-21, 42339-001-22, 42339-001-23, 42339-001-24, 42339-001-25, 42339-001-26, 42339-001-27, 42339-001-28, 42339-001-29
  • Packager: Shandong Haiyan Medical Manufacture Co., Ltd.
  • 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 August 8, 2021

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  • Active Ingredient

    Isopropyl Alcohol 70%v/v

    Purpose

    Antiseptic

  • Use

    For preparation of skin prior to injection.

  • WARNINGS

    For External use only.

    Flammable,keep away from fire or flame.

    Do not use with electrocautery procedures in eyes.

    Stop use and ask a doctor if irritation and redness develop,condition persists for more than 72 hours .

    keep out of reach of children

    In case of accidental ingestion, seek professional assistance or consult a PoisonControl Center immediately.

  • Directions

    Wipe injection site vigorously and discard.

  • Inactive ingredients

    purified water

  • PRINCIPAL DISPLAY PANEL

    haiyan001

    section text here

  • INGREDIENTS AND APPEARANCE
    ALCOHOL PREP PAD 
    isopropyl alcohol swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42339-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL0.7 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42339-001-0115 in 1 CONTAINER12/01/2017
    1200 in 1 BOX; Type 0: Not a Combination Product
    2NDC:42339-001-04100 in 1 CONTAINER12/01/2017
    250 in 1 BOX; Type 0: Not a Combination Product
    3NDC:42339-001-02100 in 1 CONTAINER12/01/2017
    3100 in 1 BOX; Type 0: Not a Combination Product
    4NDC:42339-001-033000 in 1 CONTAINER; Type 0: Not a Combination Product12/01/2017
    5NDC:42339-001-0530 in 1 CASE12/01/2017
    536 in 1 BOX; Type 0: Not a Combination Product
    6NDC:42339-001-0624 in 1 CASE12/01/2017
    650 in 1 BOX; Type 0: Not a Combination Product
    7NDC:42339-001-0724 in 1 CASE12/01/2017
    7100 in 1 BOX; Type 0: Not a Combination Product
    8NDC:42339-001-0820 in 1 CASE12/01/2017
    8140 in 1 BOX; Type 0: Not a Combination Product
    9NDC:42339-001-0930 in 1 CASE12/01/2017
    9100 in 1 BOX; Type 0: Not a Combination Product
    10NDC:42339-001-1015 in 1 CASE12/01/2017
    10200 in 1 BOX; Type 0: Not a Combination Product
    11NDC:42339-001-1120 in 1 CASE12/01/2017
    11200 in 1 BOX; Type 0: Not a Combination Product
    12NDC:42339-001-1212 in 1 CASE12/01/2017
    12100 in 1 BOX; Type 0: Not a Combination Product
    13NDC:42339-001-1348 in 1 CASE12/01/2017
    13200 in 1 BOX; Type 0: Not a Combination Product
    14NDC:42339-001-1420 in 1 CASE12/01/2017
    14200 in 1 BOX; Type 0: Not a Combination Product
    15NDC:42339-001-1524 in 1 CASE12/01/2017
    15400 in 1 BOX; Type 0: Not a Combination Product
    16NDC:42339-001-1620 in 1 CASE12/01/2017
    1650 in 1 BOX; Type 0: Not a Combination Product
    17NDC:42339-001-1720 in 1 CASE12/01/2017
    17200 in 1 BOX; Type 0: Not a Combination Product
    18NDC:42339-001-184 in 1 CASE12/01/2017
    181000 in 1 BOX; Type 0: Not a Combination Product
    19NDC:42339-001-1920 in 1 CASE12/01/2017
    19200 in 1 BOX; Type 0: Not a Combination Product
    20NDC:42339-001-2010 in 1 CASE12/01/2017
    20100 in 1 BOX; Type 0: Not a Combination Product
    21NDC:42339-001-2130 in 1 CASE12/01/2017
    2136 in 1 BOX; Type 0: Not a Combination Product
    22NDC:42339-001-2220 in 1 CASE12/01/2017
    2280 in 1 BOX; Type 0: Not a Combination Product
    23NDC:42339-001-2315 in 1 CASE12/01/2017
    23120 in 1 BOX; Type 0: Not a Combination Product
    24NDC:42339-001-2420 in 1 CASE12/01/2017
    24100 in 1 BOX; Type 0: Not a Combination Product
    25NDC:42339-001-2530 in 1 CASE12/01/2017
    25100 in 1 BOX; Type 0: Not a Combination Product
    26NDC:42339-001-2630 in 1 CASE12/01/2017
    26140 in 1 BOX; Type 0: Not a Combination Product
    27NDC:42339-001-2730 in 1 CASE12/01/2017
    27200 in 1 BOX; Type 0: Not a Combination Product
    28NDC:42339-001-2896 in 1 CASE12/01/2017
    28100 in 1 BOX; Type 0: Not a Combination Product
    29NDC:42339-001-2910 in 1 CASE12/01/2017
    29100 in 1 BOX; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34402/18/2012
    Labeler - Shandong Haiyan Medical Manufacture Co., Ltd. (421283439)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shandong Haiyan Medical Manufacture Co., Ltd. 421283439manufacture(42339-001)