Label: ALCOHOL PREP- 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 October 10, 2014

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  • Active Ingredient

    Isopropyl Alcohol 70%

  • Purpose

    Antiseptic

  • Use

    Use for preparation of the skin prior to an 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

    Apply alcohol as needed to clean intended area. Discard after single use.

  • Inactive Ingredients

    Inactive Ingredients: Purified Water

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children in case of accidental ingestion,seek professional  assistance or consult a Poison Control Center immediately.

  • PRINCIPAL DISPLAY PANEL

    kyj

  • INGREDIENTS AND APPEARANCE
    ALCOHOL PREP 
    isopropyl alcohol swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76161-001
    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:76161-001-011 in 1 PACKAGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/20/2011
    Labeler - KYJ Medical Products Co.,Ltd. (421270350)
    Establishment
    NameAddressID/FEIBusiness Operations
    KYJ Medical Products Co.,Ltd.421270350manufacture(76161-001)
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