Label: STERILE ALCOHOL PREP PADS- isopropyl alcohol liquid

  • 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 November 12, 2013

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  • ACTIVE INGREDIENT

    Active Ingredient                                       Purpose

    Isopropyl Alcohol 70% v/v                         Antiseptic


  • Purpose: Sterile alcohol prep

    For preparation of the skin prior to injection.

  • Warnings:

    • For external use only
    • Flammable, keep away from flame or fire
    • Not for use with electrocautinary devices or procedures
    • Do not use in eyes
    • Do not use if open or damaged.
  • Indications and Usage:

    Stop use and ask a doctor if:

    • Irritation or redness develops
    • condition persists for more than 72 hours
    • Cleansing of an injection site
  • Keep out of reach of children.

    In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.

  • Directions:

    Wipe injection site vigorously and discard

  • Other information:

    • Store at room temperature: 15 deg C to 30 deg C   59 deg F to 86 deg F
    • avoid excessive heat
  • Inactive Ingredient

    Inactive Ingredient

    • Water
  • Principal Display Panel

    Total Resources International

    Sterile Alcohol Prep Pad

    TRI Sterile Alcohol Prep.jpg

    Alcohol Prep pad

  • INGREDIENTS AND APPEARANCE
    STERILE ALCOHOL PREP PADS 
    isopropyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55550-031
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL0.7 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55550-031-0050 in 1 BOX
    10.45 mL in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A11/12/2013
    Labeler - Total Resources International (790160535)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shandong Haiyan Medical Manufacture Co. Ltd.421283439manufacture(55550-031)
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