Label: ALCOHOL PREP- isopropyl alcohol patch

  • NDC Code(s): 71310-202-00
  • Packager: Taizhou Kangping Medical Science And Technology 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 2, 2018

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  • Drug Facts

  • Active ingredient

    Isopropyl Alcohol 70% v/v

    Purpose

    Antiseptic

  • Use

    for the preparation of skin prior to injection and to decrease germs in minor cuts and scrapes.

    Non-sterile Solution

    Applicator is sterile if package is intact.

  • Warnings

    For external use only.

    Flammable, keep away from flame or fire.

    Stop use and ask a doctor if

    irritation develops.

    Keep out of reach of children

    except with adult supervision. If swallowed, get medical help or contat a Poison Control Center right away.

  • Directions

    • Apply topically as needed to cleanse intended area.
    • Discard after single use.
  • Inactive ingredient

    Purified water.

  • Package Labeling

    202

  • INGREDIENTS AND APPEARANCE
    ALCOHOL PREP 
    isopropyl alcohol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71310-202
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL70 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71310-202-000.4 g in 1 PACKAGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)01/30/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/30/2018
    Labeler - Taizhou Kangping Medical Science And Technology Co., Ltd. (543429840)
    Establishment
    NameAddressID/FEIBusiness Operations
    Taizhou Kangping Medical Science And Technology Co., Ltd.543429840manufacture(71310-202)