Label: STERILE ALCOHOL PREP PADS- isopropyl alcohol swab 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 February 19, 2018

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  • ACTIVE INGREDIENT

    Active Ingredient

    Isopropyl Alcohol, 70% v/v

  • PURPOSE

    Purpose

    Antiseptic

  • DOSAGE & ADMINISTRATION

    Uses

    • For preparation of the skin prior to an injection
  • INDICATIONS & USAGE

    Direction

    • Wipe injection site vigorously and discard
  • WARNINGS

    Warnings

    For External Use Only

    Flammable, keep away from fire or flame.

    Do not use

    • With electrocautery procedures
    • In the eyes

    Stop use and ask a doctor

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

  • INACTIVE INGREDIENT

    Inactive Ingredients

    • Water
  • 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
  • PRINCIPAL DISPLAY PANEL

    17005

  • INGREDIENTS AND APPEARANCE
    STERILE ALCOHOL PREP PADS 
    isopropyl alcohol swab swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71310-470
    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)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71310-470-012.5 g in 1 POUCH; Type 0: Not a Combination Product02/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A02/01/2018
    Labeler - Taizhou Kangping Medical Science And Technology Co., Ltd (543429840)
    Establishment
    NameAddressID/FEIBusiness Operations
    Taizhou Kangping Medical Science And Technology Co., Ltd543429840manufacture(71310-470)
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