Label: ALCOHOL PREP PAD- isopropyl alcohol swab

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 January 1, 2010

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  • PRINCIPAL DISPLAY PANEL

    Cat. 40000-100   NDC 34645-4242-7   Qty.1ea

    Alcohol Prep Pad
    Antiseptic * Large, 2-ply * Saturated with 70% isopropyl alcohol * For External Use Only
    Distributed by:
    Cardinal Health
    Dublin, OH 43017 USA
    Made in China

  • ACTIVE INGREDIENT

    Active ingredient
    Isopropyl Alcohol, 70% v/v

  • PURPOSE

    Purpose
    Antiseptic

  • WHEN USING

    Use
    For preparation of skin prior to 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
    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 way.
  • INDICATIONS & USAGE

    Directions
    Wipe injection site vigorously and discard

  • STORAGE AND HANDLING

    Other information
    Store at room temperature: 15。- 30。C(59。-86。F)

  • INACTIVE INGREDIENT

    Inactive ingredient
    purified water

  • PRINCIPAL DISPLAY PANEL

    Image of Pouch Label

    Pouch Label

  • INGREDIENTS AND APPEARANCE
    ALCOHOL PREP PAD 
    isopropyl alcohol swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:34645-4242
    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) 0.3 mL  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:34645-4242-70.8 mL in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33301/01/2006
    Labeler - Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. (530968767)
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