Label: ALCOHOL- isopropyl alcohol patch

  • 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 July 27, 2017

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  • Drug Facts

  • Active Ingredient

    Isopropyl Alcohol, 70% v/v

    Purpose

    Antiseptic

  • Use:

    For preparation of the skin prior to injection.

  • Warnings:

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

    Do not use:

    • longer than 1 week 
    • in the eyes

    Stop use:

    • if irritation and redness develop. If condition persists consult a doctor.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center.

  • Directions:

    Apply topically to cleanse the intended area and discard after single use.

  • Inactive Ingredient:

    Purified Water

  • Package Labeling:

    Label4

  • INGREDIENTS AND APPEARANCE
    ALCOHOL 
    isopropyl alcohol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71622-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL700 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71622-004-001 in 1 POUCH07/25/2017
    10.42 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/25/2017
    Labeler - MCL Enterprises (784754173)
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