Label: ALCOHOL- 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 July 5, 2011

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  • Active Ingredient

    Isopropyl Alcohol 70%
  • Purpose

    Antiseptic
  • Use

    Antiseptic cheanser for preparation of the skin prior to an injection
  • Warnings

    For external use only.  Flammable, keep away from fire or flame

    DO not use with electrocautery procedures. DO not use In the eyes.

    Stop Use and ask a doctor if  irritation and redness develops .If condition persists for more than 72hours, consult a physician

    Keep this and all drugs out of reach of children. In case of accidental ingestion seek professional assistance or contact a Poison Control Center immediately.
  • Directions

    Wipe injection site vigorously and discard.

    Store at room temperature, 59º-86ºF(15º-30℃). Avoid excessive heat
  • Inactive Ingredients

    Inactive Ingredients: Water
  • PRINCIPAL DISPLAY PANEL

    strip396
  • INGREDIENTS AND APPEARANCE
    ALCOHOL 
    isopropyl alcohol swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35617-396
    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:35617-396-011 in 1 PACKAGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34406/20/2011
    Labeler - NANTONG STRIP MEDICAL SUPPLY CO.,LTD. (546585519)
    Establishment
    NameAddressID/FEIBusiness Operations
    NANTONG STRIP MEDICAL SUPPLY CO.,LTD. 546585519manufacture
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