ROYAL ALCOHOL CLEANSING (ISOPROPYL ALCOHOL) PATCH [FILO AMERICA]

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ROYAL ALCOHOL CLEANSING (ISOPROPYL ALCOHOL) PATCH [FILO AMERICA]
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NDC 50435-200-00
Set ID 3849170d-63cd-42f4-8422-c9f003c8ed0c
Category HUMAN OTC DRUG LABEL
Packager Filo America
Generic Name
Product Class
Product Number
Application Number PART333A
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  • Drug Facts

  • Active Ingredient

    Isopropyl Alcohol, 70% v/v

    Purpose

    Antiseptic

  • Use

    for the preparation of skin prior to an injection to decrease germs in minor cuts and scrapes.

  • Warning:

    For external use only

    Keep out of reach of children.

    If swallowed, get medical help or contact a poison control center immediately.

    Caution do not apply to irritated skin.

    Do not ues

    in the eyes or on mucous membranes. In case of deep cuts or puncture wounds, consult a doctor.

  • Directions

    wipe injection site vigorously.

  • Other information

    store at room temperature.

  • Inactive ingredient

    water.

  • Package Labeling:

    Label

    Box

  • INGREDIENTS AND APPEARANCE
    ROYAL ALCOHOL CLEANSING 
    isopropyl alcohol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50435-200
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL70 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50435-200-00100 in 1 BOX11/13/2017
    15 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 finalpart333A11/11/2017
    Labeler - Filo America (943873703)
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