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 May 25, 2010

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  • Active Ingredient

    Isopropyl Alcohol 70%
  • Purpose

    Antiseptic
  • Use

    For preparation of skin prior to injection.
  • Warnning

    For External use only.

    Flammable,keep away from fire or flame.

    Do not use with electrocautery procedures in eyes.

    Stop use and ask a doctor if irritation and redness develop,condition persists for more than 72 hours .

    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.
  • Inactive Ingredients

    Inactive Ingredients: Water
  • PRINCIPAL DISPLAY PANEL

    Enter section text herealcohol pad

  • INGREDIENTS AND APPEARANCE
    ALCOHOL PREP PAD 
    isopropyl alcohol swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35617-394
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL0.7 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 0.3 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35617-394-011 in 1 PACKAGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34805/24/2010
    Labeler - NANTONG STRIP MEDICAL SUPPLY CO.,LTD. (546585519)
    Establishment
    NameAddressID/FEIBusiness Operations
    NANTONG STRIP MEDICAL SUPPLY CO.,LTD. 546585519manufacture
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