Label: 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 September 5, 2012

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  • Active Ingredient

    Isopropyl Alcohol, 70% v/v

  • Purpose

    Antiseptic

  • Use

    For preparation of skin prior to injection

  • 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 and ask a doctor if

    irritation or redness develop. If the condition persists for more than 72 hours, consult a doctor.

    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.

  • Directions

    Contents sterile until opened.

    Wipe injection site vigorously and discard.

  • Inactive Ingredients

    Purified water

  • Questions

    Questions or Comments about Select Medical Products? 800-777-4908


    Manufactured for PSS World Medical, Inc.

    4345 Southpoint Blvd., Jacksonville, FL 32216

    Made in China

  • Principal Display Panel

    521 ALCOHOL PREP PAD

    68345-721-01

    521 ALCOHOL PREP PAD
    2 Ply Medium Sterile
    For preparation of the skin prior to injection
    Single use only.
    Sterile unless package is opened or damaged.

  • Principal Display Panel

    527 ALCOHOL PREP PAD

    68345-720-01

    527 ALCOHOL PREP PAD
    2 Ply Lightweight Medium Sterile
    For preparation of the skin prior to injection
    Single use only.
    Sterile unless package is opened or damaged.

  • INGREDIENTS AND APPEARANCE
    ALCOHOL PREP PAD 
    isopropyl alcohol swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68345-721
    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:68345-721-010.57 mL in 1 PACKET
    2NDC:68345-721-020.91 mL in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/01/2012
    ALCOHOL PREP PAD 
    isopropyl alcohol swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68345-720
    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:68345-720-010.57 mL in 1 PACKET
    2NDC:68345-720-020.91 mL in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/01/2012
    Labeler - PSS World Medical, Inc. (101822682)
    Registrant - Specialty Medical Supplies Beijing Co., Ltd. (527931072)
    Establishment
    NameAddressID/FEIBusiness Operations
    Specialty Medical Supplies Beijing Co., Ltd.527931072manufacture(68345-721, 68345-720)
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