Label: STERILE ALCOHOL PREP PAD- 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 August 15, 2017

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  • ACTIVE INGREDIENT

    Active Ingredient

    Isopropyl Alcohol, 70% v/v

  • PURPOSE

    Purpose

    Antiseptic

  • INDICATIONS & USAGE

    Uses

    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

  • STOP USE

    Stop use and ask a doctor

    if irritation and redness develops
    If condition persists for more than 72 hours, consult a physician

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

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

  • DOSAGE & ADMINISTRATION

    Directions

    Wipe injection site vigorously and discard

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Water

  • PRINCIPAL DISPLAY PANEL

    Alcohol Wipe

  • INGREDIENTS AND APPEARANCE
    STERILE ALCOHOL PREP PAD 
    isopropyl alcohol swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71310-001
    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:71310-001-702.5 g in 1 POUCH; Type 0: Not a Combination Product08/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/01/2017
    Labeler - Taizhou Kangping Medical Science And Technology Co., Ltd (543429840)
    Registrant - Taizhou Kangping Medical Science And Technology Co., Ltd (543429840)
    Establishment
    NameAddressID/FEIBusiness Operations
    Taizhou Kangping Medical Science And Technology Co., Ltd543429840manufacture(71310-001)
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