Label: ALCOHOL PREP PAD 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 March 19, 2010

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  • ACTIVE INGREDIENT

    Active Ingredients:

    Isopropyl Alcohol USP, 70% v/v

  • PURPOSE

    Purpose

    Antiseptic

  • INDICATIONS & USAGE

    Use:  For preparation of skin prior to an injection to decrease germs in minor cuts and scrapes.

  • WARNINGS

    Warnings:  For external use only.

  • 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.

  • GENERAL PRECAUTIONS

    Caution:  Do not apply to irritated skin.

  • DO NOT USE

    Do not use in the eyes or on mucous membranes.  In case of deep or puncture wounds, consult a doctor.

  • DOSAGE & ADMINISTRATION

    Directions:  Wipe injection site vigorously.

  • STORAGE AND HANDLING

    Other information:  Store at room temperature.

  • INACTIVE INGREDIENT

    Inactive Ingredients:  Water

  • SPL UNCLASSIFIED SECTION

    Manufactured by:

    Specialty Medical Supplies

    Coral Springs, FL 33065

    1-877-787-2435

    www.specialtymedicalsupplies.com

    Made in China

  • PRINCIPAL DISPLAY PANEL

    100 Individual Pads

    NDC: 68113-996-01

    Alcohol Prep Pads

    Antiseptic for preparation of the skin prior to injection

    For Individual, Professional, and Hospital Use

    Saturated with 70% v/v Isopropyl Alcohol for external use only

    SMS Alcohol Prep Pad Labeling

    SMS Alcohol Prep Pad Labeling

  • INGREDIENTS AND APPEARANCE
    ALCOHOL PREP PAD 
    alcohol prep pad liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68113-996
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Isopropyl Alcohol (UNII: ND2M416302) (Isopropyl Alcohol - UNII:ND2M416302) Isopropyl Alcohol70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68113-996-01100 in 1 BOX
    170 mL in 1 POUCH
    2NDC:68113-996-02200 in 1 BOX
    270 mL in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E01/01/2005
    Labeler - Caribbean Medical Brokers (018354907)
    Establishment
    NameAddressID/FEIBusiness Operations
    Specialty Medical Supplies Beijing Co., Ltd.527931072manufacture
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